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Clinical trialNCT01365793CompletedPhase 3Interventional

Randomized Control Trial of Fluid Therapy for Pediatric Diabetic Ketoacidosis

SponsorUniversity of California, DavisEnrollment1,389Cerebral EdemaDiabetic Ketoacidosis
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

13 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • University of California, Davis

    Sacramento, California, United States

  • Children'S Hospital Colorado

    Aurora, Colorado, United States

  • Alfred I. Dupont Hospital for Children

    Wilmington, Delaware, United States

  • Children'S National Medical Center

    Washington D.C., District of Columbia, United States

  • Ann & Robert Lurie Children'S Hospital of Chicago

    Chicago, Illinois, United States

  • Children'S Hospital Boston

    Boston, Massachusetts, United States

  • Washington University & St. Louis Children'S Hospital

    St Louis, Missouri, United States

  • Columbia University

    New York, New York, United States

  • Nationwide Children'S Hospital

    Columbus, Ohio, United States

  • the Children'S Hospital of Philadelphia

    Philadelphia, Pennsylvania, United States

  • Hasbro Children'S Hospital/rhode Island Hospital

    Providence, Rhode Island, United States

  • Texas Children'S Hospital

    Houston, Texas, United States

  • University of Utah

    Salt Lake City, Utah, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

0.45% saline intravenous fluid0.45% saline replacement fluid0.9% saline Intravenous fluid0.9% saline replacement fluid
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Nov 2010
Primary completion
30 Sept 2016
Completion
31 Jan 2017
Last update posted
25 Jun 2018
Registered enrollment
1,389
Registry id
NCT01365793

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.