Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

Conditions
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Diabetes

Intervention / Treatment
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* Other: slow fluid rate
* Other: fast fluid rate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: slow fluid rate<br>bolus 10 ml/kg of NS followed by 1.25 times maintenance rate | Other: slow fluid rate<br>* 10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance<br>* Other names: normal saline;|
| Active Comparator: Fast fluid rate<br>bolus 20 ml/kg of NS followed by 1.5 times maintenance rate | Other: fast fluid rate<br>* 20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | start of treatment until resolution of DKA an expected average of 12 to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the length of treatment | Length of treatment was defined as a time of the hospital stay after the start of IVF infusion | discharge from the hospital, an expected average of 1-2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketoacidosis Fluids