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

NCT01343758 | Completed

• 1 other identifier: 05-11-153
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroenteritis; Dehydration

Outcome Measures

Primary Outcomes (1)

• Admission Rate

  The investigators will measure what percentage of patients in each treatment group are admitted.

  During emergency department visit

Secondary Outcomes (1)

• Change in Serum Ketones

  1 and 2 hours after treatment given

Study Arms (2)

5% dextrose in normal saline

ACTIVE COMPARATOR

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

Other: 5% dextrose in normal saline

Normal Saline Bolus

NO INTERVENTION

Interventions

5% dextrose in normal saline OTHER

Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline

5% dextrose in normal saline

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• months to 6 years of age
• Gastroenteritis
• Requires IV fluids for dehydration

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Children's Hospital: lead
• Abbott: collaborator

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Gastroenteritis; Dehydration

Interventions

Glucose; Saline Solution

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Jason A Levy, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2011
• First Posted: April 28, 2011
• Study Start: January 1, 2007
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 24, 2012

Record last verified: 2012-02

Locations

US (1)