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Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

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ClinicalTrials.gov Identifier: NCT01365793
Recruitment Status : Completed
First Posted : June 3, 2011
Results First Posted : June 25, 2018
Last Update Posted : June 25, 2018
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cerebral Edema
Diabetic Ketoacidosis
Interventions Drug: 0.45% saline replacement fluid
Drug: 0.9% saline replacement fluid
Drug: 0.45% saline intravenous fluid
Drug: 0.9% saline Intravenous fluid
Enrollment 1389

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Period Title: Overall Study
Started 344 351 345 349
Completed 342 344 338 347
Not Completed 2 7 7 2
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid Total
Hide Arm/Group Description This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm. Total of all reporting groups
Overall Number of Baseline Participants 344 351 345 349 1389
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 351 participants 345 participants 349 participants 1389 participants
0 to less than 6 years old
43
  12.5%
42
  12.0%
42
  12.2%
35
  10.0%
162
  11.7%
6 to less than 18 years old
301
  87.5%
309
  88.0%
303
  87.8%
314
  90.0%
1227
  88.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 344 participants 351 participants 345 participants 349 participants 1389 participants
Female
179
  52.0%
187
  53.3%
187
  54.2%
186
  53.3%
739
  53.2%
Male
165
  48.0%
164
  46.7%
158
  45.8%
163
  46.7%
650
  46.8%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 344 participants 351 participants 345 participants 349 participants 1389 participants
White
235
  68.3%
232
  66.1%
247
  71.6%
243
  69.6%
957
  68.9%
Black or African American
73
  21.2%
82
  23.4%
68
  19.7%
63
  18.1%
286
  20.6%
Other
19
   5.5%
14
   4.0%
16
   4.6%
23
   6.6%
72
   5.2%
Unknown
17
   4.9%
23
   6.6%
14
   4.1%
20
   5.7%
74
   5.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Ethnicity Number Analyzed 344 participants 351 participants 345 participants 349 participants 1389 participants
Hispanic or Latino
48
  14.0%
62
  17.7%
49
  14.2%
69
  19.8%
228
  16.4%
Not Hispanic or Latino, Other, or Unknown
296
  86.0%
289
  82.3%
296
  85.8%
280
  80.2%
1161
  83.6%
1.Primary Outcome
Title the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)
Hide Description The primary outcome is the binary indicator that a patient's GCS score drops below 14 (i.e. abnormal score) within the first 24 hours of treatment of DKA. There will be two treatment factors: sodium concentration of re-hydration fluids and rate of rehydration. These effects will be tested separately, using the Mantel-Haenszel chi-square test, stratified by hospital, and by the other main factor.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with a GCS of 14 or 15 at randomization
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description:
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Overall Number of Participants Analyzed 337 345 338 341
Measure Type: Count of Participants
Unit of Measure: Participants
10
   3.0%
11
   3.2%
11
   3.3%
16
   4.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rapid Rehydration Using 0.45% Saline Replacement Fluid, Rapid Rehydration Using 0.9% Saline Replacement Fluid, Slower Rehydration Using 0.45% Saline Replacement Fluid, Slower Rehydration Using 0.9% Saline Replacement Fluid
Comments The study uses a factorial experimental design, and tests two null hypotheses. The first of these hypotheses - the frequency of GCS score declines to <14 is equal between the Rapid Rehydration and Slower Rehydration groups - is reported here. The analysis of the second hypothesis is reported below.
Type of Statistical Test Superiority
Comments Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).
Statistical Test of Hypothesis P-Value 0.34
Comments The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rapid Rehydration Using 0.45% Saline Replacement Fluid, Rapid Rehydration Using 0.9% Saline Replacement Fluid, Slower Rehydration Using 0.45% Saline Replacement Fluid, Slower Rehydration Using 0.9% Saline Replacement Fluid
Comments The study uses a factorial experimental design, and tests the two null hypotheses. The second of these hypotheses - the frequency of GCS score declines to <14 is equal between the 0.45% Saline group and the 0.90% Saline group - is reported here. The analysis of the first hypothesis is reported above.
Type of Statistical Test Superiority
Comments Each statistical test uses stratification to adjust for enrolling hospital, and the arm not being tested (e.g., the test for rapid vs slower rehydration is stratified by 0.45% and 0.9% Saline, and vice versa).
Statistical Test of Hypothesis P-Value 0.43
Comments The a priori threshold for statistical significance for each of the 2 p-values is 0.025, for an overall significance of 0.50.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Frequency of Clinically Apparent Brain Injury
Hide Description Deterioration in neurological status requiring interventions such as hyperosmolar therapy or endotracheal intubation, or resulting in death. This outcome was determined by an adjudication committee.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients.
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description:
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Overall Number of Participants Analyzed 344 351 345 349
Measure Type: Count of Participants
Unit of Measure: Participants
2
   0.6%
2
   0.6%
5
   1.4%
3
   0.9%
3.Secondary Outcome
Title Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)
Hide Description The Digit Span subtest is adapted from the Wechsler Intelligence Scale for Children, 4th version (WISC-IV) and it assesses working memory. It consists of a Digit Span Forward task in which individuals are asked to repeat numbers in the same sequence as they were presented verbally and a Digit Span Backward task in which participants repeat the numbers in the reversed order to which they were heard. Each task yields a score ranging from 0 to 16. Higher scores represent better outcomes for this test. The trajectory of digit span scores during the course of the hospitalization was used to assess improvements in mental status and whether these varied systematically as a function of treatment protocol. Digit span measurements were collected every four hours during waking hours (7AM to 10PM). The measure analyzed is the average linear change in scores between enrollment and either 24-hours or DKA resolution, whichever occurred first.
Time Frame 24 hours
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized patients with digit span measured during DKA
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description:
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Overall Number of Participants Analyzed 344 351 345 349
Mean (Standard Error)
Unit of Measure: Digit Span Change per Hour
Digit span recall test Forward slope 0.065  (0.010) 0.058  (0.010) 0.046  (0.010) 0.039  (0.010)
Digit span recall test Backward slope 0.052  (0.009) 0.053  (0.009) 0.042  (0.009) 0.043  (0.009)
4.Secondary Outcome
Title Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.
Hide Description Contextual memory was assessed via color and spatial-position tasks. Color-Task: black-ink items on a white square background were shown on a computer screen with a colored border. Subjects were asked to remember the item and the item’s border color. Items were shown for 1 second, followed by a 1-second interval in which a fixation point was shown. Then, subjects were given a self-paced recognition test including studied drawings and new drawings shown in random order with no color border. Subjects determined if they had seen the drawing before. For recognized drawings, subjects reported the previously shown border color. Spatial-Position task: identical to the color task except that the items instead varied in their spatial position on the computer screen. The item-context association rate is the rate of correct item-color and item-spatial position recalled over the total of previously viewed items correctly recognized. Score range: 0-1 with higher scores indicating a better outcome.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects aged 6 years old and older with 3-month follow-up and successful completion of memory score tests, and d-prime (a measure of chance agreement) >0.50
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description:
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Overall Number of Participants Analyzed 175 184 178 176
Mean (Standard Deviation)
Unit of Measure: Item-context association rate
0.60  (0.14) 0.60  (0.14) 0.61  (0.14) 0.60  (0.14)
5.Secondary Outcome
Title Intelligence Quotient (IQ) Testing
Hide Description IQ was assessed with the WASI (6-18 year olds) or WPPSI-III (3-5 year olds) at the 3 month follow-up visit. The Wechsler Abbreviated Scale of Intelligence (WASI) is a measure of IQ designed for individuals aged 6 to 89. The WASI includes four subtests; the Block Design and Matrix Reasoning tests measure Performance IQ, and the Vocabulary and Similarities tests measure Verbal IQ. Full scale IQ was computed from these scores and used for analyses. Scores typically vary from 75 to 135 with higher scores representing a better outcome.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized subjects aged 3 years and older with 3-month follow-up and successful completion of IQ testing.
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description:
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm.
This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
Overall Number of Participants Analyzed 187 201 191 189
Mean (Standard Deviation)
Unit of Measure: IQ points
102  (12) 102  (13) 102  (13) 103  (13)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Hide Arm/Group Description This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved more rapid intravenous fluid treatment which included a second 10cc/Kg bolus of 0.9% saline and assumed a 10% fluid deficit. Intravenous fluids were infused to replace half of the estimated fluid deficit over 12 hours and the remaining half over the following 24 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.45% saline was used as the replacement fluid for this arm. This arm involved slower rehydration (assumed 5% fluid deficit and no additional fluid bolus). Intravenous fluids were infused to replace the estimated deficit over 48 hours, in addition to maintenance fluids. 0.9% saline was used as the replacement fluid for this arm.
All-Cause Mortality
Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/342 (0.29%)      0/344 (0.00%)      0/338 (0.00%)      0/347 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/342 (1.46%)      4/344 (1.16%)      11/338 (3.25%)      10/347 (2.88%)    
Cardiac disorders         
Cardiac Arrest   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Gastrointestinal disorders         
Abdominal pain upper   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Pancreatitis   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Hepatobiliary disorders         
Hepatomegaly   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Infections and infestations         
Infection   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Metabolism and nutrition disorders         
Acidosis   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Acidosis hyperchloraemic   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Diabetic ketoacidosis   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Hypoglycaemia   1/342 (0.29%)  2 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Nervous system disorders         
Brain oedema   2/342 (0.58%)  2 2/344 (0.58%)  2 8/338 (2.37%)  8 7/347 (2.02%)  7
Cerebral infarction   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Somnolence   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Renal and urinary disorders         
Renal injury   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Acute respiratory distress syndrome   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Pneumothorax   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Vascular disorders         
Hypovolemic shock   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Rapid Rehydration Using 0.45% Saline Replacement Fluid Rapid Rehydration Using 0.9% Saline Replacement Fluid Slower Rehydration Using 0.45% Saline Replacement Fluid Slower Rehydration Using 0.9% Saline Replacement Fluid
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   112/342 (32.75%)      124/344 (36.05%)      117/338 (34.62%)      129/347 (37.18%)    
Blood and lymphatic system disorders         
Coagulopathy   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Lymphadenopathy   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Cardiac disorders         
Bradycardia   1/342 (0.29%)  1 1/344 (0.29%)  1 2/338 (0.59%)  2 1/347 (0.29%)  1
Nodal Rythm   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Tachycardia   3/342 (0.88%)  3 2/344 (0.58%)  2 3/338 (0.89%)  3 1/347 (0.29%)  1
Ventricular Extrasystoles   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Ear and labyrinth disorders         
Ear pain   2/342 (0.58%)  2 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Middle ear effusion   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Endocrine disorders         
Hypothyroidism   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Eye disorders         
Eye irritation   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Eye pain   2/342 (0.58%)  2 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Ocular hyperaemia   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Vision blurred   2/342 (0.58%)  3 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Gastrointestinal disorders         
Abdominal distension   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Abdominal pain   2/342 (0.58%)  2 11/344 (3.20%)  11 7/338 (2.07%)  7 3/347 (0.86%)  3
Abdominal pain lower   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Abdominal pain upper   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Abdominal tenderness   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Constipation   3/342 (0.88%)  3 4/344 (1.16%)  4 2/338 (0.59%)  2 11/347 (3.17%)  11
Diarrhoea   0/342 (0.00%)  0 1/344 (0.29%)  1 1/338 (0.30%)  1 0/347 (0.00%)  0
Dyspepsia   3/342 (0.88%)  3 1/344 (0.29%)  1 1/338 (0.30%)  1 1/347 (0.29%)  1
Dysphagia   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Gastrointestinal sounds abnormal   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Gastrooesophageal reflux disease   2/342 (0.58%)  2 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Gingival pain   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Glossodynia   1/342 (0.29%)  1 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Haematemesis   1/342 (0.29%)  1 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Haematochezia   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Mouth ulceration   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Nausea   5/342 (1.46%)  5 3/344 (0.87%)  3 2/338 (0.59%)  2 5/347 (1.44%)  5
Oesophageal discomfort   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Oesophagitis   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Oral Pain   0/342 (0.00%)  0 0/344 (0.00%)  0 3/338 (0.89%)  3 0/347 (0.00%)  0
Pancreatitis acute   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Proctalgia   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Stomatitis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Toothache   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Vomiting   2/342 (0.58%)  2 4/344 (1.16%)  4 2/338 (0.59%)  2 4/347 (1.15%)  4
General disorders         
Catheter site inflammation   2/342 (0.58%)  2 2/344 (0.58%)  2 0/338 (0.00%)  0 2/347 (0.58%)  2
Catheter site pain   3/342 (0.88%)  3 0/344 (0.00%)  0 2/338 (0.59%)  2 3/347 (0.86%)  3
Chest discomfort   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Chest pain   1/342 (0.29%)  1 2/344 (0.58%)  2 4/338 (1.18%)  4 2/347 (0.58%)  2
Chills   1/342 (0.29%)  1 1/344 (0.29%)  1 1/338 (0.30%)  1 0/347 (0.00%)  0
Complication associated with device   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Crying   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Facial pain   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Hypothermia   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Infusion site extravasation   0/342 (0.00%)  0 1/344 (0.29%)  1 1/338 (0.30%)  1 2/347 (0.58%)  2
Infusion site pain   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Injection site pain   0/342 (0.00%)  0 0/344 (0.00%)  0 2/338 (0.59%)  2 0/347 (0.00%)  0
Oedema peripheral   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Pain   1/342 (0.29%)  1 1/344 (0.29%)  1 2/338 (0.59%)  2 0/347 (0.00%)  0
Peripheral swelling   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 2/347 (0.58%)  2
Pyrexia   8/342 (2.34%)  8 11/344 (3.20%)  11 8/338 (2.37%)  8 10/347 (2.88%)  10
Infections and infestations         
Abscess   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Bacteraemia   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Candida infection   1/342 (0.29%)  1 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Candiduria   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Cellulitis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Clostridium difficile colitis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Fungal infection   0/342 (0.00%)  0 1/344 (0.29%)  1 1/338 (0.30%)  1 0/347 (0.00%)  0
Lice infestation   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Metapneumovirus infection   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Oral candidiasis   0/342 (0.00%)  0 2/344 (0.58%)  2 0/338 (0.00%)  0 2/347 (0.58%)  2
Otitits media   2/342 (0.58%)  2 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Periorbital cellulitis   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Pharyngitis   0/342 (0.00%)  0 2/344 (0.58%)  2 1/338 (0.30%)  1 1/347 (0.29%)  1
Pharyngitis streptococcal   0/342 (0.00%)  0 2/344 (0.58%)  2 0/338 (0.00%)  0 1/347 (0.29%)  1
Pneumonia   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Pyuria   2/342 (0.58%)  2 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Sinusitis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Skin candida   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Tooth infection   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Upper respiratory tract infection   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Urethritis   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Urinary tract infection   0/342 (0.00%)  0 0/344 (0.00%)  0 3/338 (0.89%)  3 3/347 (0.86%)  3
Vaginal infection   0/342 (0.00%)  0 2/344 (0.58%)  2 0/338 (0.00%)  0 0/347 (0.00%)  0
Vulvovaginal candidiasis   2/342 (0.58%)  2 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Vulvovaginal mycotic infection   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Vuvlovaginitis   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Injury, poisoning and procedural complications         
Heart injury   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Medication error   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Post procedural haemorrhage   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Investigations         
Amylase increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood bicarbonate decreased   1/342 (0.29%)  1 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Blood chloride increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood creatinine phosphokinase decreased   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Blood glucose decreased   1/342 (0.29%)  1 3/344 (0.87%)  3 2/338 (0.59%)  2 4/347 (1.15%)  4
Blood glucose increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood immunoglobulin A increased   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Blood ketone body increased   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Blood magnesium decreased   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Blood osmolarity decreased   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Blood phosphorus decreased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 3/347 (0.86%)  3
Blood potassium decreased   0/342 (0.00%)  0 3/344 (0.87%)  3 1/338 (0.30%)  1 2/347 (0.58%)  2
Blood potassium increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood pressure increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood sodium decreased   1/342 (0.29%)  1 0/344 (0.00%)  0 2/338 (0.59%)  2 0/347 (0.00%)  0
Blood sodium increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood thyroid stimulating hormone increased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Blood urea decreased   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Cardiac murmur   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Coma scale abnormal   0/342 (0.00%)  0 4/344 (1.16%)  4 1/338 (0.30%)  2 0/347 (0.00%)  0
Crystal urine present   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Electrocardiogram QT prolonged   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Electrocardiogram T wave peaked   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Influenza A virus test positive   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Lipase increased   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Liver function test increased   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Streptococcus test positive   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Urinary casts   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Urine analysis abnormal   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Urine output decreased   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
White blood cell count increased   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Metabolism and nutrition disorders         
Acidosis   2/342 (0.58%)  2 0/344 (0.00%)  0 3/338 (0.89%)  3 2/347 (0.58%)  2
Acidosis hyperchloraemic   3/342 (0.88%)  3 16/344 (4.65%)  16 4/338 (1.18%)  4 20/347 (5.76%)  20
Alkalosis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Dehydration   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Hyperchloraemia   3/342 (0.88%)  3 2/344 (0.58%)  2 0/338 (0.00%)  0 2/347 (0.58%)  2
Hyperglycaemia   0/342 (0.00%)  0 3/344 (0.87%)  3 0/338 (0.00%)  0 1/347 (0.29%)  1
Hyperkalaemia   8/342 (2.34%)  8 4/344 (1.16%)  4 4/338 (1.18%)  4 1/347 (0.29%)  1
Hypernatraemia   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 3/347 (0.86%)  3
Hyperphosphataemia   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Hypertriglyceridaemia   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Hypocalcaemia   0/342 (0.00%)  0 2/344 (0.58%)  2 0/338 (0.00%)  0 0/347 (0.00%)  0
Hypoglycaemia   10/342 (2.92%)  10 9/344 (2.62%)  10 12/338 (3.55%)  13 15/347 (4.32%)  17
Hypokalaemia   8/342 (2.34%)  9 15/344 (4.36%)  15 8/338 (2.37%)  8 15/347 (4.32%)  16
Hypomagnesaemia   3/342 (0.88%)  3 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Hyponatraemia   4/342 (1.17%)  4 0/344 (0.00%)  0 5/338 (1.48%)  5 0/347 (0.00%)  0
Hypophagia   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Hypophosphataemia   3/342 (0.88%)  3 5/344 (1.45%)  5 2/338 (0.59%)  2 5/347 (1.44%)  5
Musculoskeletal and connective tissue disorders         
Arthralgia   0/342 (0.00%)  0 2/344 (0.58%)  2 0/338 (0.00%)  0 0/347 (0.00%)  0
Back pain   0/342 (0.00%)  0 2/344 (0.58%)  2 1/338 (0.30%)  1 1/347 (0.29%)  1
Musculoskeletal chest pain   1/342 (0.29%)  1 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Musculoskeletal pain   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Myalgia   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Neck pain   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Pain in extremity   2/342 (0.58%)  2 3/344 (0.87%)  3 1/338 (0.30%)  1 5/347 (1.44%)  5
Trismus   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Nervous system disorders         
Brain oedema   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Dizziness   3/342 (0.88%)  3 1/344 (0.29%)  1 1/338 (0.30%)  1 1/347 (0.29%)  1
Dysarthria   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Headache   29/342 (8.48%)  29 16/344 (4.65%)  16 23/338 (6.80%)  23 28/347 (8.07%)  31
Seizure   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Syncope   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Psychiatric disorders         
Agitation   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Anxiety   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Confusional state   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Insomnia   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Irritability   1/342 (0.29%)  1 1/344 (0.29%)  2 1/338 (0.30%)  1 1/347 (0.29%)  1
Mental status changes   5/342 (1.46%)  5 5/344 (1.45%)  5 4/338 (1.18%)  4 6/347 (1.73%)  6
Suicidal ideation   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Renal and urinary disorders         
Haematuria   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Incontinence   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Urinary incontinence   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Reproductive system and breast disorders         
Vaginal discharge   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 1/347 (0.29%)  1
Vulvovaginal pruritis   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough   3/342 (0.88%)  3 1/344 (0.29%)  1 2/338 (0.59%)  2 1/347 (0.29%)  1
Dyspnoea   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Epistaxis   1/342 (0.29%)  1 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Hypoxia   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Nasal congestion   1/342 (0.29%)  1 1/344 (0.29%)  1 2/338 (0.59%)  2 0/347 (0.00%)  0
Oropharyngeal pain   9/342 (2.63%)  9 11/344 (3.20%)  11 10/338 (2.96%)  10 9/347 (2.59%)  9
Pharyngeal erythema   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Pneumonia aspiration   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Pulmonary oedema   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Rhinorrhoea   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Stridor   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Tachypnoea   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Throat irritation   0/342 (0.00%)  0 1/344 (0.29%)  1 0/338 (0.00%)  0 0/347 (0.00%)  0
Wheezing   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Skin and subcutaneous tissue disorders         
Decubitus ulcer   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Dry skin   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Pruritis   1/342 (0.29%)  1 1/344 (0.29%)  1 1/338 (0.30%)  1 2/347 (0.58%)  2
Rash   3/342 (0.88%)  3 1/344 (0.29%)  1 4/338 (1.18%)  4 3/347 (0.86%)  3
Rash erythematous   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Rash pruritic   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Skin disorder   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Skin warm   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Swelling face   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Urticaria   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Vascular disorders         
Flushing   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Hypertension   4/342 (1.17%)  4 0/344 (0.00%)  0 1/338 (0.30%)  1 1/347 (0.29%)  1
Hypotension   0/342 (0.00%)  0 2/344 (0.58%)  2 2/338 (0.59%)  2 0/347 (0.00%)  0
Orthostatic hypotension   1/342 (0.29%)  1 0/344 (0.00%)  0 0/338 (0.00%)  0 0/347 (0.00%)  0
Peripheral coldness   0/342 (0.00%)  0 0/344 (0.00%)  0 1/338 (0.30%)  1 0/347 (0.00%)  0
Phlebitis   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 1/347 (0.29%)  1
Poor peripheral circulation   0/342 (0.00%)  0 0/344 (0.00%)  0 0/338 (0.00%)  0 2/347 (0.58%)  2
Indicates events were collected by systematic assessment
Fluid infusion rates for this study represent the upper and lower ends of DKA protocols in use. Rates above or below this range were not evaluated. There were fewer patients with GCS decline to <14 than anticipated.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Nathan Kuppermann
Organization: University of California, Davis (UC Davis Health)
Phone: 916-734-1535
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT01365793     History of Changes
Other Study ID Numbers: 230233
U01HD062417 ( U.S. NIH Grant/Contract )
First Submitted: June 1, 2011
First Posted: June 3, 2011
Results First Submitted: March 5, 2018
Results First Posted: June 25, 2018
Last Update Posted: June 25, 2018