Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
Primary Purpose
Gastroenteritis, Dehydration
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
5% dextrose in normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Gastroenteritis
Eligibility 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
Sites / Locations
- Children's Hospital Boston
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
5% dextrose in normal saline
Normal Saline Bolus
Arm Description
This group will receive a bolus of normal saline that contains 5% dextrose
Outcomes
Primary Outcome Measures
Admission Rate
The investigators will measure what percentage of patients in each treatment group are admitted.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01343758
First Posted
April 27, 2011
Last Updated
February 22, 2012
Sponsor
Boston Children's Hospital
Collaborators
Abbott
1. Study Identification
Unique Protocol Identification Number
NCT01343758
Brief Title
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Boston Children's Hospital
Collaborators
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroenteritis, Dehydration
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
5% dextrose in normal saline
Arm Type
Active Comparator
Arm Description
This group will receive a bolus of normal saline that contains 5% dextrose
Arm Title
Normal Saline Bolus
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
5% dextrose in normal saline
Intervention Description
Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline
Primary Outcome Measure Information:
Title
Admission Rate
Description
The investigators will measure what percentage of patients in each treatment group are admitted.
Time Frame
During emergency department visit
Secondary Outcome Measure Information:
Title
Change in Serum Ketones
Description
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.
Time Frame
1 and 2 hours after treatment given
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason A Levy, MD
Organizational Affiliation
Boston Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
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