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Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Primary Purpose

Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
slow fluid rate
fast fluid rate
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes focused on measuring Ketoacidosis Fluids

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • the Childrens Hospital Colorado

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

slow fluid rate

Fast fluid rate

Arm Description

bolus 10 ml/kg of NS followed by 1.25 times maintenance rate

bolus 20 ml/kg of NS followed by 1.5 times maintenance rate

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

the length of treatment
Length of treatment was defined as a time of the hospital stay after the start of IVF infusion

Full Information

First Posted
October 1, 2012
Last Updated
October 3, 2012
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT01701557
Brief Title
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Official Title
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes
Keywords
Ketoacidosis Fluids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
slow fluid rate
Arm Type
Active Comparator
Arm Description
bolus 10 ml/kg of NS followed by 1.25 times maintenance rate
Arm Title
Fast fluid rate
Arm Type
Active Comparator
Arm Description
bolus 20 ml/kg of NS followed by 1.5 times maintenance rate
Intervention Type
Other
Intervention Name(s)
slow fluid rate
Other Intervention Name(s)
normal saline
Intervention Description
10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
Intervention Type
Other
Intervention Name(s)
fast fluid rate
Other Intervention Name(s)
normal saline
Intervention Description
20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
Primary Outcome Measure Information:
Title
time to normalization of bicarbonate and pH
Description
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)
Time Frame
start of treatment until resolution of DKA an expected average of 12 to 24 hours
Secondary Outcome Measure Information:
Title
the length of treatment
Description
Length of treatment was defined as a time of the hospital stay after the start of IVF infusion
Time Frame
discharge from the hospital, an expected average of 1-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arleta Rewers, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
the Childrens Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26823137
Citation
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.
Results Reference
derived

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Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

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