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Cerebral Edema in Pediatric Diabetic Ketoacidosis

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ClinicalTrials.gov Identifier: NCT00629707
Recruitment Status : Completed
First Posted : March 6, 2008
Results First Posted : September 12, 2012
Last Update Posted : September 18, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Diabetic Ketoacidosis
Intervention Other: intravenous fluid treatment
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Slow Fluid Infusion Rapid Fluid Infusion
Hide Arm/Group Description Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours. More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
Period Title: Overall Study
Started 10 10
Completed 10 8
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Physician Decision             0             1
Arm/Group Title Slow Fluid Infusion Rapid Fluid Infusion Total
Hide Arm/Group Description Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours. More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume. Total of all reporting groups
Overall Number of Baseline Participants 10 10 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
<=18 years
10
 100.0%
10
 100.0%
20
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 20 participants
14.2  (3.4) 11.4  (1.8) 12.9  (3.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 20 participants
Female
4
  40.0%
5
  50.0%
9
  45.0%
Male
6
  60.0%
5
  50.0%
11
  55.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 20 participants
10 10 20
1.Primary Outcome
Title Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)
Hide Description In both groups, brain Apparent Diffusion Coefficient (ADC) measures at 3-6 hours and 9-12 hours after beginning DKA treatment were averaged to determine overall brain ADC during DKA treatment. The brain ADC indicates the distribution of water in the brain and is an indicator of brain swelling (edema). The overall brain ADC values during DKA treatment were compared with the brain ADC measured after recovery to assess the degree of brain edema formation during DKA treatment. The difference in brain ADC, calculated as the averaged treatment values minus the recovery value, was used as the main outcome measure to indicate the degree of brain edema formation
Time Frame twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Data from all enrolled participant that completed the study were analyzed.
Arm/Group Title Slow Fluid Infusion Rapid Fluid Infusion
Hide Arm/Group Description:
Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours.
More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
Overall Number of Participants Analyzed 10 8
Mean (Standard Deviation)
Unit of Measure: mm^2/sec
36  (30) 48  (41)
2.Secondary Outcome
Title Brain NAA/Creatine Ratio & Brain Lactate Measured by MR Spectroscopy, Cerebral Blood Flow & Oxygen Saturation Measured by MR Perfusion Weighted Imaging & Near Infrared Spectroscopy, Mental Status Evaluated by Glasgow Coma Scale Scores.
Hide Description [Not Specified]
Time Frame twice during DKA treatment, once at 3-6 hours and at 9-12 after treatment. A normal comparison measurement will be done after recovery from DKA, at least 72 hours after treatment
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Slow Fluid Infusion Rapid Fluid Infusion
Hide Arm/Group Description Slower infusion rate: Patients in this arm will receive an initial intravenous fluid bolus of 10cc/Kg followed by rehydration calculated to replace a deficit of 7.5% of body weight over 48 hours. More rapid infusion: Patients in this arm will receive an initial bolus of 20 cc/Kg of intravenous fluids followed by replacement of an estimated deficit of 10% of body weight over 36 hours plus replacement of 1/2 of urine output volume.
All-Cause Mortality
Slow Fluid Infusion Rapid Fluid Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Slow Fluid Infusion Rapid Fluid Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)    
Nervous system disorders     
altered mental status  [1]  0/10 (0.00%)  0 1/10 (10.00%)  1
Indicates events were collected by systematic assessment
[1]
Alteration in mental status during DKA treatment of sufficient severity for suspicion of clinically-apparent cerebral edema
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Slow Fluid Infusion Rapid Fluid Infusion
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      1/10 (10.00%)    
Endocrine disorders     
hypoglycemia  [1]  0/10 (0.00%)  0 1/10 (10.00%)  2
Indicates events were collected by systematic assessment
[1]
blood glucose level below 70 mg/dL during DKA treatment
Study terminated after enrollment of 20 subjects. Review of data from these subjects showed minimal difference between groups and substantial variability suggesting that a larger sample would be very unlikely to show significant differences.
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: Dr. Nicole Glaser
Organization: University of California, Davis
Phone: 916-734-7098
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00629707     History of Changes
Other Study ID Numbers: R01NS048610 ( U.S. NIH Grant/Contract )
R01NS052619-01 ( U.S. NIH Grant/Contract )
R01NS052592-01 ( U.S. NIH Grant/Contract )
First Submitted: March 4, 2008
First Posted: March 6, 2008
Results First Submitted: June 18, 2012
Results First Posted: September 12, 2012
Last Update Posted: September 18, 2012