Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Diabetes

Treatments: Other: fast fluid rate; Other: slow fluid rate

Study type: Interventional

Funder types: Other

Identifiers

NCT01701557

06-0846

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

slow fluid rate

Active Comparator group

Description:

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

Treatment:

Other: slow fluid rate

Fast fluid rate

Active Comparator group

Description:

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

Treatment:

Other: fast fluid rate