Ignite Creation Date:
2025-12-24 @ 6:37 PM
Ignite Modification Date:
2025-12-27 @ 12:43 AM
Study NCT ID:
NCT01701557
Status:
COMPLETED
Last Update Posted:
2012-10-05
First Post:
2012-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Sponsor:
University of Colorado, Denver
Organization:
Study Overview
Official Title:
Fluid Resuscitation for Pediatric Diabetic Ketoacidosis
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: