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

Boston Children's Hospital

Status: Completed

Conditions: Dehydration; Gastroenteritis

Treatments: Other: 5% dextrose in normal saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01343758

05-11-153

Details and patient eligibility

About

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.

Enrollment: 188 estimated patients

Sex: All

Ages: 6 months to 6 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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188 participants in 2 patient groups

5% dextrose in normal saline

Active Comparator group

Description:

This group will receive a bolus of normal saline that contains 5% dextrose

Treatment:

Other: 5% dextrose in normal saline

Normal Saline Bolus

No Intervention group