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Completed

NCT Number: NCT01701557

Fluid Resuscitation for Pediatric Diabetic Ketoacidosis

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

Completed

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Childrens Hospital Colorado

Aurora, Colorado, 80045, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

slow fluid rate

Other

10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance

Other names: normal saline

fast fluid rate

Other

20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance

Other names: normal saline

Primary outcomes

  1. time to normalization of bicarbonate and pH

    Time frame: 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 outcomes

  1. the length of treatment

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 5, 2012
Registry last updated
Oct 5, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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