CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,389 enrolled
Drug / intervention
0.45% saline replacement fluid +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01365793
NCT01365793Phase 3Completed
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Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis

University of California, Davis·interventional·Posted Jun 3, 2011·Updated Jun 25, 2018

In Brief

A Phase 3 clinical trial evaluating 0.45% saline replacement fluid, 0.9% saline replacement fluid, and 2 other interventions for Cerebral Edema and Diabetic Ketoacidosis. Completed, enrolled 1,389 participants across 13 sites.

Detailed Summary

The investigators will conduct a randomized controlled trial comparing four different intravenous (IV) fluid treatment protocols for pediatric diabetic ketoacidosis (DKA). Two rates of rehydration will be compared; a more rapid rate and a slower rate. Within each of these two basic rehydration protocols, the investigators will vary the type of rehydration fluid used (0.9% saline or 0.45% saline). The investigators will compare the different treatments by conducting assessments of neurological injury, by measuring the frequency of significant cerebral edema, and by measuring long-term neurocognitive function. These studies will allow us to determine whether variations in IV fluid treatment protocols affect acute neurological outcomes of DKA. Additionally, they will provide important data regarding the impact of DKA and DKA treatment on long-term neurocognitive function in children. In this way, the investigators hope to identify a more ideal fluid management strategy for children with DKA. Previous studies have suggested that DKA may cause blood flow to the brain to be reduced and that brain injury might result from this reduction in blood flow and/or the effects of re-establishment of normal blood flow during DKA treatment with insulin and iv fluids. The investigators hypothesize that more rapidly re-establishing normal blood flow to the brain during DKA, by giving fluids more rapidly and using fluids with a higher sodium (salt) content, will help to minimize brain injury caused by DKA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebral Edema, Diabetic Ketoacidosis
CountriesUnited States
CollaboratorsEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 3, 2011
Enrollment StartNov 1, 2010
Primary CompletionSep 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 15.1 years ago

Interventions

0.45% saline replacement fluiddrug

10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid

0.9% saline replacement fluiddrug

10cc/Kg bolus of 0.9% saline followed by 0.9% saline used as the replacement fluid.

0.45% saline intravenous fluiddrug

0.45% saline fluid

0.9% saline Intravenous fluiddrug

0.9% saline fluid