Trial Outcomes & Findings for Cerebral Edema in Pediatric Diabetic Ketoacidosis (NCT NCT00629707)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2012-09-18

Participant Flow

Participant milestones

Participant milestones
Measure	Slow Fluid Infusion 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.	Rapid Fluid Infusion 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 Study STARTED	10	10
Overall Study COMPLETED	10	8
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Slow Fluid Infusion 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.	Rapid Fluid Infusion 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 Study Withdrawal by Subject	0	1
Overall Study Physician Decision	0	1

Baseline Characteristics

Cerebral Edema in Pediatric Diabetic Ketoacidosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Slow Fluid Infusion n=10 Participants 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.	Rapid Fluid Infusion n=10 Participants 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 n=20 Participants Total of all reporting groups
Age, Categorical <=18 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	14.2 years STANDARD_DEVIATION 3.4 • n=5 Participants	11.4 years STANDARD_DEVIATION 1.8 • n=7 Participants	12.9 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Population: Data from all enrolled participant that completed the study were analyzed.

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

Outcome measures

Outcome measures
Measure	Slow Fluid Infusion n=10 Participants 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.	Rapid Fluid Infusion n=8 Participants 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.
Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)	36 mm^2/sec Standard Deviation 30	48 mm^2/sec Standard Deviation 41

SECONDARY outcome

Timeframe: 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 measures

Outcome data not reported

Adverse Events

Slow Fluid Infusion

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rapid Fluid Infusion

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Slow Fluid Infusion n=10 participants at risk 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.	Rapid Fluid Infusion n=10 participants at risk 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.
Nervous system disorders altered mental status	0.00% 0/10	10.0% 1/10 • Number of events 1

Other adverse events

Other adverse events
Measure	Slow Fluid Infusion n=10 participants at risk 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.	Rapid Fluid Infusion n=10 participants at risk 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.
Endocrine disorders hypoglycemia	0.00% 0/10	10.0% 1/10 • Number of events 2

Additional Information

Dr. Nicole Glaser

University of California, Davis

Phone: 916-734-7098

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place