NCT01285713

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 28, 2011

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
11 months until next milestone

Results Posted

Study results publicly available

January 23, 2013

Completed
Last Updated

March 19, 2019

Status Verified

February 1, 2019

Enrollment Period

11 months

First QC Date

January 27, 2011

Results QC Date

December 14, 2012

Last Update Submit

February 26, 2019

Conditions

Dehydration

Keywords

DehydrationGastroenteritisDehydration in Gastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Measurement of Serum Ketones Before and After Administration of Intravenous Fluids for Acute Gastroenteritis

    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.

    4 hours

Study Arms (2)

5% Dextrose (D5) in Normal Saline (NS)

EXPERIMENTAL

10cc/kg D5NS, followed by 30cc/kg NS

Drug: 5% Dextrose (D5) in Normal Saline (NS)

Normal Saline (NS)

ACTIVE COMPARATOR

10cc/kg NS, followed by 30cc/kg NS

Drug: Normal Saline (NS)

Interventions

5% Dextrose (D5) in Normal Saline (NS)DRUG

D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS

Also known as: D5NS
5% Dextrose (D5) in Normal Saline (NS)
Normal Saline (NS)DRUG

NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS

Also known as: NS
Normal Saline (NS)

Eligibility Criteria

Age2 Months - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

DehydrationGastroenteritis

Interventions

GlucoseSaline Solution

Condition Hierarchy (Ancestors)

Water-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Limitations and Caveats

Single center study Small sample size Enrollment available 16 hours/day Evaluated one dextrose load of 500mg/kg

Results Point of Contact

Title
Dr. Kari Posner
Organization
New York University, Langone Medical Center
kariposner@gmail.com
212-263-7300

Study Officials

  • Elizabeth R Alpern, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

  • Kari Posner, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2011

First Posted

January 28, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

March 1, 2012

Last Updated

March 19, 2019

Results First Posted

January 23, 2013

Record last verified: 2019-02

Locations

US(1)