Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01701557
First received: October 1, 2012
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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


Condition Intervention
Diabetes
Other: slow fluid rate
Other: fast fluid rate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • time to normalization of bicarbonate and pH [ Time Frame: start of treatment until resolution of DKA an expected average of 12 to 24 hours ] [ Designated as safety issue: No ]
    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)


Secondary Outcome Measures:
  • the length of treatment [ Time Frame: discharge from the hospital, an expected average of 1-2 days ] [ Designated as safety issue: No ]
    Length of treatment was defined as a time of the hospital stay after the start of IVF infusion


Enrollment: 50
Study Start Date: November 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: slow fluid rate
bolus 10 ml/kg of NS followed by 1.25 times maintenance rate
Other: slow fluid rate
10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
Other Name: normal saline
Active Comparator: Fast fluid rate
bolus 20 ml/kg of NS followed by 1.5 times maintenance rate
Other: fast fluid rate
20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
Other Name: normal saline

Detailed Description:

A randomized trial of two initial volumes of IVF and subsequent administration rates. Group I received 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance and Group II received 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance. The specific variables measured included demographics (age, gender, and race/ethnicity) and routine laboratory values (pH, pCO2, plasma glucose, electrolytes, bicarbonate, sodium, chloride, BUN. Length of treatment was defined as a time of the hospital stay after the start of IVF infusion.

  Eligibility

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1 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.)

Exclusion Criteria:

  • requirement for additional fluid resuscitation for hemodynamic instability
  • weight greater than 70 kilograms
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01701557

Locations
United States, Colorado
the Childrens Hospital Colorado
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Arleta Rewers, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01701557     History of Changes
Other Study ID Numbers: 06-0846
Study First Received: October 1, 2012
Last Updated: October 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Ketoacidosis Fluids

Additional relevant MeSH terms:
Diabetic Ketoacidosis
Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Diabetes Complications
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 22, 2014