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

This study has been completed.
Sponsor:
Collaborator:
Abbott
Information provided by:
Children's Hospital Boston
ClinicalTrials.gov Identifier:
NCT01343758
First received: April 27, 2011
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Gastroenteritis
Dehydration
Other: 5% dextrose in normal saline

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind Randomized Controlled Clinical Trial Investigating the Use of Intravenous Dextrose for Dehydration and Ketosis in Children With Gastroenteritis and Dehydration.

Resource links provided by NLM:


Further study details as provided by Children's Hospital Boston:

Primary Outcome Measures:
  • Admission Rate [ Time Frame: During emergency department visit ] [ Designated as safety issue: No ]
    The investigators will measure what percentage of patients in each treatment group are admitted.


Secondary Outcome Measures:
  • Change in Serum Ketones [ Time Frame: 1 and 2 hours after treatment given ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 188
Study Start Date: January 2007
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 5% dextrose in normal saline
This group will receive a bolus of normal saline that contains 5% dextrose
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
No Intervention: Normal Saline Bolus

  Eligibility

Ages Eligible for Study:   6 Months to 6 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01343758

Locations
United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Children's Hospital Boston
Abbott
Investigators
Principal Investigator: Jason A Levy, MD Children's Hospital Boston
  More Information

No publications provided

Responsible Party: Jason Levy (PI), Children's Hospital Boston
ClinicalTrials.gov Identifier: NCT01343758     History of Changes
Other Study ID Numbers: 05-11-153
Study First Received: April 27, 2011
Last Updated: February 22, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Dehydration
Gastroenteritis
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 23, 2014