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Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01701557
First Posted: October 5, 2012
Last Update Posted: October 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01701557     History of Changes
Other Study ID Numbers: 06-0846
First Submitted: October 1, 2012
First Posted: October 5, 2012
Last Update Posted: October 5, 2012
Last Verified: October 2012

Keywords provided by University of Colorado, Denver:
Ketoacidosis Fluids

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


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