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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01343758
Recruitment Status : Completed
First Posted : April 28, 2011
Last Update Posted : February 24, 2012
Information provided by:
Boston Children's Hospital

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.

Condition or disease Intervention/treatment Phase
Gastroenteritis Dehydration Other: 5% dextrose in normal saline Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 188 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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.
Study Start Date : January 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Admission Rate [ Time Frame: During emergency department visit ]
    The investigators will measure what percentage of patients in each treatment group are admitted.

Secondary Outcome Measures :
  1. Change in Serum Ketones [ Time Frame: 1 and 2 hours after treatment given ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 6 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01343758

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United States, Massachusetts
Children's Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
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Principal Investigator: Jason A Levy, MD Boston Children's Hospital
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Responsible Party: Jason Levy (PI), Children's Hospital Boston Identifier: NCT01343758    
Other Study ID Numbers: 05-11-153
First Posted: April 28, 2011    Key Record Dates
Last Update Posted: February 24, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Gastrointestinal Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes