Study Investigating the Use of Intravenous Fluids With Dextrose for Dehydrated Children
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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. |
- 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.
- 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 |
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| United States, Massachusetts | |
| Children's Hospital Boston | |
| Boston, Massachusetts, United States, 02115 | |
| 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 June 17, 2013