Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children

Overview

Infants and young children often become infected with gastroenteritis leading to vomiting and diarrhea. This can lead to dehydration, one of the most common complaints in the Pediatric Emergency Department. These children are often in need of treatment with intravenous (IV) fluids. While the investigators know that IV fluids work, it is not clear which type or how much fluid is the best amount to give. Currently, the most common type of IV fluid given is salt water, also called normal saline. In contrast to adults, infants and young children with dehydration often have a build up of a certain type of acid in their blood which can perpetuate the nausea, vomiting, and general malaise associated with gastroenteritis. The investigators feel that giving these children IV fluids with lots of sugar (in addition to the salt) reduces the acid more rapidly than giving just salt water alone. In a prior study, the investigators have shown that children who receive lower amounts of sugar in the IV fluids return to the Emergency Department more often for a second visit. Based on this study, the investigators believe that children who receive the sugar-salt solution will do better than children who receive just normal saline. The investigators will determine if the sugar-salt solution is better by giving equal numbers of children the sugar-salt solution and normal saline and then see what happens to each child. The investigators will monitor who needs to be admitted, how much each child vomits, how much each child drinks, and also the level of acid in the blood before and after getting the IV fluid. After the study is completed, the investigators can compare the two different groups (children who received the sugar-salt solution versus children who received normal saline alone) to determine if one group had greater improvement and better clinical outcome than the other.

Full Title of Study: “A Double-blind Randomized Controlled Clinical Trial Investigating the Use of Intravenous Dextrose for Dehydration and Ketosis in Children With Gastroenteritis and Dehydration.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: July 2011

Interventions

  • Other: 5% dextrose in normal saline
    • Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline

Arms, Groups and Cohorts

  • Active Comparator: 5% dextrose in normal saline
    • This group will receive a bolus of normal saline that contains 5% dextrose
  • No Intervention: Normal Saline Bolus

Clinical Trial Outcome Measures

Primary Measures

  • Admission Rate
    • Time Frame: During emergency department visit
    • The investigators will measure what percentage of patients in each treatment group are admitted.

Secondary Measures

  • Change in Serum Ketones
    • Time Frame: 1 and 2 hours after treatment given
    • The investigators will measure the change in serum ketones at 1 and 2 hours after the study fluid is given and compare the mean change in each treatment group.

Participating in This Clinical Trial

Inclusion Criteria

  • 6 months to 6 years of age – Gastroenteritis – Requires IV fluids for dehydration Exclusion Criteria:

  • Chronic disease – Comorbid condition – Received IV fluids or antiemetics in the last 12 hours – Symptoms for more than 7 days – Blood glucose less than 40

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 6 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boston Children’s Hospital
  • Collaborator
    • Abbott
  • Provider of Information About this Clinical Study
    • Jason Levy (PI), Children’s Hospital Boston
  • Overall Official(s)
    • Jason A Levy, MD, Principal Investigator, Boston Children’s Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.