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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rapid Rehydration Using 0.45% Saline Replacement Fluid 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.
Rapid Rehydration Using 0.9% Saline Replacement Fluid 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.
Slower Rehydration Using 0.45% Saline Replacement Fluid 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.
Slower Rehydration Using 0.9% Saline Replacement Fluid 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.

Participant Flow:   Overall Study
    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
STARTED   344   351   345   349 
COMPLETED   342   344   338   347 
NOT COMPLETED   2   7   7   2 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Rapid Rehydration Using 0.45% Saline Replacement Fluid 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.
Rapid Rehydration Using 0.9% Saline Replacement Fluid 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.
Slower Rehydration Using 0.45% Saline Replacement Fluid 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.
Slower Rehydration Using 0.9% Saline Replacement Fluid 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 Total of all reporting groups

Baseline Measures
   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 
Overall Participants Analyzed 
[Units: Participants]
 344   351   345   349   1389 
Age, Customized 
[Units: Participants]
Count of Participants
         
0 to less than 6 years old   43   42   42   35   162 
6 to less than 18 years old   301   309   303   314   1227 
Sex: Female, Male 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
         
Race           
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 
[Units: Participants]
Count of Participants
         
Ethnicity           
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% 


  Outcome Measures

1.  Primary:   the Number of Participants With Glasgow Coma Score (GCS) < 14 Within the First 24 Hours of Treatment for Diabetic Ketoacidosis (DKA)   [ Time Frame: 24 hours ]

2.  Secondary:   Frequency of Clinically Apparent Brain Injury   [ Time Frame: 24 hours ]

3.  Secondary:   Hourly Improvement in Forward and Backward Digit Span Scores During DKA Treatment (Mean Difference Per Hour)   [ Time Frame: 24 hours ]

4.  Secondary:   Mean Scores on Tests of Memory Capacity 3 Months After Recovery From DKA.   [ Time Frame: 3 months ]

5.  Secondary:   Intelligence Quotient (IQ) Testing   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information

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
e-mail: nkuppermann@ucdavis.edu


Publications:

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