Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
1 other identifier
interventional
50
1 country
1
Brief Summary
Randomized trial to determine if the volume of fluid administration in pediatric patients with DKA impacts the rate of normalization of serum bicarbonate, pH as well as the length of treatment
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Nov 2007
Typical duration for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 1, 2012
CompletedFirst Posted
Study publicly available on registry
October 5, 2012
CompletedOctober 5, 2012
October 1, 2012
2.6 years
October 1, 2012
October 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to normalization of bicarbonate and pH
Laboratory parameters were measured hourly for the first 4 hours, and every 2 to3 hours thereafter until acid-base normalization (pH was above 7.3 or the HCO3 was above 15 mmol/L)
start of treatment until resolution of DKA an expected average of 12 to 24 hours
Secondary Outcomes (1)
the length of treatment
discharge from the hospital, an expected average of 1-2 days
Study Arms (2)
slow fluid rate
ACTIVE COMPARATORbolus 10 ml/kg of NS followed by 1.25 times maintenance rate
Fast fluid rate
ACTIVE COMPARATORbolus 20 ml/kg of NS followed by 1.5 times maintenance rate
Interventions
10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
Eligibility Criteria
You may qualify if:
- day to 18 years of age
- type 1 diabetes
- presence of DKA, as defined by glucose \>250 mg/dl, accumulation of ketone bodies in the blood, and metabolic acidosis (venous pH \< 7.30 or serum bicarbonate \< 15 mmol/L.)
You may not qualify if:
- requirement for additional fluid resuscitation for hemodynamic instability
- weight greater than 70 kilograms
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the Childrens Hospital Colorado
Aurora, Colorado, 80045, United States
Related Publications (1)
Bakes K, Haukoos JS, Deakyne SJ, Hopkins E, Easter J, McFann K, Brent A, Rewers A. Effect of Volume of Fluid Resuscitation on Metabolic Normalization in Children Presenting in Diabetic Ketoacidosis: A Randomized Controlled Trial. J Emerg Med. 2016 Apr;50(4):551-9. doi: 10.1016/j.jemermed.2015.12.003. Epub 2016 Jan 25.
PMID: 26823137DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arleta Rewers, MD
University of Colorado, Denver
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2012
First Posted
October 5, 2012
Study Start
November 1, 2007
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
October 5, 2012
Record last verified: 2012-10