Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: slow fluid rate; Other: fast fluid rate

• Registration Number: NCT01701557
• Lead Sponsor: University of Colorado, Denver

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 Timeline

• Study Start: 2007-11
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2012-10
• Study First Submitted: 2012-10-01
• Study First Submitted QC: 2012-10-03
• Last Update Submitted: 2012-10-03
• Study First Posted: 2012-10-05
• Last Update Posted: 2012-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.)

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Exclusion Criteria

• requirement for additional fluid resuscitation for hemodynamic instability
• weight greater than 70 kilograms

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
slow fluid rate	slow fluid rate	bolus 10 ml/kg of NS followed by 1.25 times maintenance rate
Fast fluid rate	fast fluid rate	bolus 20 ml/kg of NS followed by 1.5 times maintenance rate

Primary Outcome Measures

Name	Time	Method
time to normalization of bicarbonate and pH	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

Name	Time	Method
the length of treatment	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

Trial Locations

Locations (1)

the Childrens Hospital Colorado; 🇺🇸 Aurora, Colorado, United States