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

A Double-blind Randomized Controlled Clinical Trial Investigating the Use of Intravenous Dextrose for Dehydration and Ketosis in Children With Gastroenteritis and Dehydration.

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.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; Dehydration
• Intervention / Treatment: Other: 5% dextrose in normal saline

• Study Type: Interventional
• Enrollment (Anticipated): 188
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Children's Hospital Boston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 6 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Serum Ketones	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.	1 and 2 hours after treatment given

Collaborators and Investigators

• Sponsor: Boston Children's Hospital
• Collaborators: Abbott
• Investigators: Principal Investigator: Jason A Levy, MD, Boston Children's Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): July 1, 2011

Study Registration Dates

• First Submitted: April 27, 2011
• First Submitted That Met QC Criteria: April 27, 2011
• First Posted (ESTIMATE): April 28, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 24, 2012
• Last Update Submitted That Met QC Criteria: February 22, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Metabolic Diseases; Gastrointestinal Diseases; Water-Electrolyte Imbalance; Gastroenteritis; Dehydration
• Other Study ID Numbers: 05-11-153