Clinical trial NCT01343758: 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
Overall status: COMPLETED
Phase: NA
Conditions: Gastroenteritis
Dehydration
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2011-04-28
Enrollment: 188
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Admission Rate
timeFrame: During emergency department visit
Secondary outcomes:
measure: Change in Serum Ketones
timeFrame: 1 and 2 hours after treatment given
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Jason A Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: