Clinical Trial: Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Fluid Therapy and Cerebral Injury in Pediatric Diabetic Ketoacidosis

Brief 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.

Detailed Summary: These data will be compared to observational data from children with type 1 diabetes without DKA.
Sponsor: University of California, Davis

Current Primary Outcome: Glasgow Coma Score < 14 within the first 24 hours of treatment for DKA. [ Time Frame: 24 hours ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Frequency of clinically apparent cerebral edema during DKA treatment [ Time Frame: 24 hours ]
  GCS scores between the 4 groups will be compared using a Wilcoxon rank- sum test or a Van Elteren test, stratified by hospital. Patients presenting with GCS scores < 14 will be included in this analysis. The outcome will be difference between GCS score at presentation and lowest recorded GCS score, with death as the worst possible ranking.
• Median scores on digit span testing during DKA treatment [ Time Frame: 24 hours ]
  Digit span scores are measured as the longest span correctly recited in each of the assessment sessions. Separate analyses will be conducted for the forward and backward spans. Digit span scores can be analyzed using para- metric methods. The trajectory of digit span scores during the course of the hospitalization can be used to assess patients rates of recovery and whether this rate varies systematically as a function of treatment protocol.
• Mean scores on tests of memory capacity 3 months after recovery from DKA. [ Time Frame: 3 months ]
  The effects of treatment conditions on memory function will be examined in separate analyses of variance (ANOVA) in which each of the indices of the memory performance will be considered as outcomes. The proposed memory tasks yield two indices of performance, recollection of item-context associations and item recognition. Memory function after recovery from DKA will also be compared with memory function of children with type 1 diabetes without DKA.
• Mean scores on IQ tests 3 months after recovery from DKA [ Time Frame: 3 months ]
  The same analytical approach proposed for memory will be used for the analyses of IQ measures. Each test will provide three scores: a verbal IQ, and performance IQ, and a total IQ score. Each of these three IQ measures will be analyzed using ANOVA. Mean IQ scores will also be compared with IQ scores of children with type 1 diabetes without DKA.

Original Secondary Outcome:

• Frequency of clinically apparent cerebral edema during DKA treatment [ Time Frame: 24 hours ]
  GCS scores between the 4 groups will be compared using a Wilcoxon rank- sum test or a Van Elteren test, stratified by hospital. Patients presenting with GCS scores < 14 will be included in this analysis. The outcome will be difference between GCS score at presentation and lowest recorded GCS score, with death as the worst possible ranking.
• Median scores on digit span testing during DKA treatment [ Time Frame: 24 hours ]
  Digit span scores are measured as the longest span correctly recited in each of the assessment sessions. Separate analyses will be conducted for the forward and backward spans. Digit span scores can be analyzed using para- metric methods. The trajectory of digit span scores during the course of the hospitalization can be used to assess patients rates of recovery and whether this rate varies systematically as a function of treatment protocol.
• Mean scores on tests of memory capacity 3 months after recovery from DKA. [ Time Frame: 3 months ]
  The effects of treatment conditions on memory function will be examined in separate analyses of variance (ANOVA) in which each of the indices of the memory performance will be considered as outcomes. The proposed memory tasks yield two indices of performance, recollection of item-context associa- tions and item recognition.
• Mean scores on IQ tests 3 months after recovery from DKA [ Time Frame: 3 months ]
  The same analytical approach proposed for memory will be used for the analyses of IQ measures. Each test will provide three scores: a verbal IQ, and performance IQ, and a total IQ score. Each of these three IQ measures will be analyzed using ANOVA.

Dates:
Date Received: June 1, 2011
Date Started: November 2010
Date Completion:
Last Updated: May 12, 2017
Last Verified: May 2017