Diabetes
Conditions
Keywords
Ketoacidosis Fluids
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.
Interventions
OTHERslow 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
OTHERfast 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
Sponsors
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 18 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed