Clinical Trial: IV Glucose for Dehydration Treatment

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration

Brief Summary: To determine whether the addition of dextrose to IV fluids in the treatment of gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of dextrose containing fluids in the treatment of gastroenteritis will be assessed.

Detailed Summary:

Background: Evaluation and treatment of dehydration in gastroenteritis is a cornerstone of pediatric emergency medicine, however there are no standard regimens or guidelines for the amount or type of fluids administered when a child requires intravenous hydration. Reduced carbohydrate intake in gastroenteritis leads to free fatty acid breakdown, excess ketones, and an increased likelihood for continued nausea and vomiting. Glucose therapy can treat this catabolic metabolism, improving the ability to overcome dehydration and starvation, and facilitate a child's return to baseline. There has been no previous randomized controlled study examining the utility of early intravenous dextrose in the treatment of gastroenteritis.

Objectives: To determine whether the addition of dextrose to IV fluids in the treatment of gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of dextrose containing fluids in the treatment of gastroenteritis will be assessed.

Methods: This is a double blinded randomized controlled trial of children between the ages of 2 months and 12 years presenting to the Children's Hospital of Philadelphia (CHOP) Emergency Department (ED) who have gastroenteritis diagnosed by the ED attending or fellow and require intravenous hydration. Subjects will be randomized to either receive intravenous fluids containing dextrose or intravenous fluids without dextrose. The primary outcome measure is change in serum ketones during the intervention. Secondary outcomes are assessment of the clinical benefits of dextrose containing fluids in terms of persistence of emesis, satisfaction after treatment (physician and parental survey), admission rates, revisits within 1 week to the emergency department or to primary care physician, length of illness and parental assessment of time to return to base
Sponsor: Children's Hospital of Philadelphia

Current Primary Outcome: Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis [ Time Frame: 4 hours ]

Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.


Original Primary Outcome: To Determine Whether the Addition of Dextrose to IV Fluids (IVF) in the Treatment of Gastroenteritis Affects Serum Ketones [ Time Frame: 4 hours ]

Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.


Current Secondary Outcome: Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes [ Time Frame: 4 hours ]

Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.


Original Secondary Outcome: To Assess the Benefits of Dextrose Containing IVF on Clinically Relevant Outcomes [ Time Frame: 4 hours ]

Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.


Information By: Children's Hospital of Philadelphia

Dates:
Date Received: January 27, 2011
Date Started: September 2010
Date Completion:
Last Updated: April 1, 2013
Last Verified: March 2013