Phase 2 N=83 Randomized Triple-blind Treatment

IV Glucose for Dehydration Treatment

Dehydration

Bottom Line

View on ClinicalTrials.gov: NCT01285713 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2013

Primary outcome: Primary: Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis — 1.10; 2.39 mmol/L — p=0.0003

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 5% Dextrose (D5) in Normal Saline (NS) (Drug); Normal Saline (NS) (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Children's Hospital of Philadelphia
Primary completion: Aug 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis	1.10; 2.39	0.0003 sig

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01285713). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.