NCT00629707

Brief Summary

The purpose of this trial is to compare two different rates of fluid administration during diabetic ketoacidosis (DKA) treatment in children to determine which fluid administration rate is more beneficial for brain metabolism and for preventing or decreasing brain swelling during DKA.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2008

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

September 12, 2012

Completed
Last Updated

September 18, 2012

Status Verified

September 1, 2012

Enrollment Period

2.7 years

First QC Date

March 4, 2008

Results QC Date

June 18, 2012

Last Update Submit

September 12, 2012

Conditions

Diabetic Ketoacidosis

Keywords

diabetic ketoacidosisDKAcerebral edemabrain edema

Outcome Measures

Primary Outcomes (1)

  • Cerebral Edema Measured by MR Imaging (Apparent Diffusion Coefficient)

    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

    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

Secondary Outcomes (1)

  • 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.

    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

Study Arms (2)

1

ACTIVE COMPARATOR

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.

Other: intravenous fluid treatment

2

ACTIVE COMPARATOR

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.

Other: intravenous fluid treatment

Interventions

intravenous fluid treatmentOTHER

infusion of intravenous fluids (0.9% saline and 0.45% saline)

12

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • age 8-18 years
  • diagnosis of diabetic ketoacidosis
  • able to cooperate with MR scanning

You may not qualify if:

  • pre-existing cerebral injury or brain structural abnormality
  • dental hardware or other metal devices which would interfere with MR imaging

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, Davis Medical Center, 2315 Stockton Blvd

Sacramento, California, 95817, United States

Location

Related Publications (3)

  • Trainor JL, Glaser NS, Tzimenatos L, Stoner MJ, Brown KM, McManemy JK, Schunk JE, Quayle KS, Nigrovic LE, Rewers A, Myers SR, Bennett JE, Kwok MY, Olsen CS, Casper TC, Ghetti S, Kuppermann N; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Clinical and Laboratory Predictors of Dehydration Severity in Children With Diabetic Ketoacidosis. Ann Emerg Med. 2023 Aug;82(2):167-178. doi: 10.1016/j.annemergmed.2023.01.001. Epub 2023 Apr 5.

    PMID: 37024382DERIVED

  • Rewers A, Kuppermann N, Stoner MJ, Garro A, Bennett JE, Quayle KS, Schunk JE, Myers SR, McManemy JK, Nigrovic LE, Trainor JL, Tzimenatos L, Kwok MY, Brown KM, Olsen CS, Casper TC, Ghetti S, Glaser NS; Pediatric Emergency Care Applied Research Network (PECARN) FLUID Study Group. Effects of Fluid Rehydration Strategy on Correction of Acidosis and Electrolyte Abnormalities in Children With Diabetic Ketoacidosis. Diabetes Care. 2021 Sep;44(9):2061-2068. doi: 10.2337/dc20-3113. Epub 2021 Jun 29.

    PMID: 34187840DERIVED

  • Kuppermann N, Ghetti S, Schunk JE, Stoner MJ, Rewers A, McManemy JK, Myers SR, Nigrovic LE, Garro A, Brown KM, Quayle KS, Trainor JL, Tzimenatos L, Bennett JE, DePiero AD, Kwok MY, Perry CS 3rd, Olsen CS, Casper TC, Dean JM, Glaser NS; PECARN DKA FLUID Study Group. Clinical Trial of Fluid Infusion Rates for Pediatric Diabetic Ketoacidosis. N Engl J Med. 2018 Jun 14;378(24):2275-2287. doi: 10.1056/NEJMoa1716816.

    PMID: 29897851DERIVED

MeSH Terms

Conditions

Diabetic KetoacidosisBrain Edema

Condition Hierarchy (Ancestors)

KetosisAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Dr. Nicole Glaser
Organization
University of California, Davis
nsglaser@ucdavis.edu
916-734-7098

Study Officials

  • Nicole Glaser, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2008

First Posted

March 6, 2008

Study Start

June 1, 2008

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

September 18, 2012

Results First Posted

September 12, 2012

Record last verified: 2012-09

Locations

US(1)