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IV Glucose for Dehydration Treatment

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ClinicalTrials.gov Identifier: NCT01285713
Recruitment Status : Completed
First Posted : January 28, 2011
Results First Posted : January 23, 2013
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To determine whether the addition of dextrose to IV fluids in the treatment of gastroenteritis leads to a decrease in serum ketones. Secondarily, the clinical benefits of dextrose containing fluids in the treatment of gastroenteritis will be assessed.

Condition or disease Intervention/treatment Phase
Dehydration Drug: 5% Dextrose (D5) in Normal Saline (NS) Drug: Normal Saline (NS) Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration
Study Start Date : September 2010
Primary Completion Date : August 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 5% Dextrose (D5) in Normal Saline (NS)
10cc/kg D5NS, followed by 30cc/kg NS
Drug: 5% Dextrose (D5) in Normal Saline (NS)
D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS
Other Name: D5NS
Active Comparator: Normal Saline (NS)
10cc/kg NS, followed by 30cc/kg NS
Drug: Normal Saline (NS)
NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS
Other Name: NS


Outcome Measures

Primary Outcome Measures :
  1. Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis [ Time Frame: 4 hours ]
    Measurement of serum ketones by bedside ketone meter before and after administration of IVF for both groups to determine a change in serum ketones. The hypothesis is that dextrose containing IVF will lead to a decrease in serum ketones in children with acute gastroenteritis who require IV rehydration.


Secondary Outcome Measures :
  1. Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes [ Time Frame: 4 hours ]
    Hypothesis 2: Admission rates, revisits to the emergency department (ED) or primary care physician, and length of illness will be decreased with the addition of dextrose to IVF. Physician and parental satisfaction will be increased with the addition of dextrose to IVF.


Eligibility Criteria

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Ages Eligible for Study:   2 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females age 2 months to 12th birth date
  2. Gastroenteritis (as diagnosed by ED attending or fellow physician)
  3. Need for IV fluids
  4. Dextrose stick of greater than 60 and less than 170
  5. Parental/guardian English speaking and granting informed consent

Exclusion Criteria:

  1. Underlying chronic disease affecting glucose metabolism or reason/persistence of symptoms: Renal failure, Diabetes Mellitus, Diabetes Insipidus, Metabolic Disorder, VP shunt, Migraine Headaches
  2. Shock
  3. Vomiting greater than 72 hours since onset of illness
  4. Patients that have received IV fluids at an outside institution within 12 hours
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01285713


Locations
United States, Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
American Academy of Pediatrics
Academic Pediatric Association
Investigators
Principal Investigator: Elizabeth R Alpern, MD Children's Hospital of Philadelphia
Principal Investigator: Kari Posner, MD New York University School of Medicine
More Information

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01285713     History of Changes
Other Study ID Numbers: 10-007632
First Posted: January 28, 2011    Key Record Dates
Results First Posted: January 23, 2013
Last Update Posted: January 11, 2018
Last Verified: January 2018

Keywords provided by Children's Hospital of Philadelphia:
Dehydration
Gastroenteritis
Dehydration in Gastroenteritis

Additional relevant MeSH terms:
Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes