IV Glucose for Dehydration Treatment

This study has been completed.
Sponsor:
Collaborators:
American Academy of Pediatrics
Academic Pediatric Association
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01285713
First received: January 27, 2011
Last updated: April 1, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Dehydration
Drug: 5% Dextrose (D5) in Normal Saline (NS)
Drug: Normal Saline (NS)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Glucose Containing Fluid in the Treatment of Acute Dehydration

Resource links provided by NLM:


Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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:
  • Dextrose Containing Intravenous Fluids (IVF) Affect Clinically Relevant Outcomes [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: September 2010
Study Completion Date: March 2012
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 Langone Medical Center
  More Information

No publications provided

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01285713     History of Changes
Other Study ID Numbers: 10-007632
Study First Received: January 27, 2011
Results First Received: December 14, 2012
Last Updated: April 1, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 24, 2014