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

Dehydration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01343758
• Other study ID #: 05-11-153
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: February 22, 2012
• Start date: January 2007
• Est. completion date: July 2011

Study information

• Verified date: February 2012
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Months to 6 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dehydration
• Gastroenteritis

Intervention

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

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Admission Rate	The investigators will measure what percentage of patients in each treatment group are admitted.	During emergency department visit	No
Secondary	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	No