Efficacy Study of IV Fluids Only vs Ondansetron to Treat... | NCT00691275

Studies
Efficacy Study of IV Fluids Only vs Ondansetron to Treat Dehydration

NCT00691275

Sponsor

Children's Hospitals and Clinics of Minnesota

Status

Withdrawn

Last Update Posted

Jul 14, 2015Estimated

Enrollment

0Actual

Phase

Not Applicable

Conditions

Dehydration
Gastroenteritis

Interventions

Ondansetron
Saline

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Sep 2009Estimated

Completion Date

Sep 2009Estimated

First Submitted Date

Jun 3, 2008

First Submission Date that Met QC Criteria

Jun 4, 2008

First Posted Date

Jun 5, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 13, 2015

Last Update Posted Date

Jul 14, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Children's Hospitals and Clinics of MinnesotaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Dehydration due to vomiting is a common complication of acute gastroenteritis in children. Persistent vomiting following rehydration is a problem in outpatient management using oral rehydration therapy.

Four previous studies have examined the role of the medication, ondansetron, in treating nausea and vomiting in children with gastroenteritis and have suggested that it may be beneficial [1-4]. A previous study has also shown that the administration of intravenous fluid alone to children with dehydration due to gastroenteritis helps resolve nausea and vomiting in the majority of patients [5]. None of the previous studies compared the efficacy of intravenous ondansetron with that of intravenous fluid alone in the prevention of vomiting . In addition, the previous studies were limited by poorly defined inclusion criteria and outcome measures.

The proposed study seeks to more clearly define the role of intravenous ondansetron in the management of children suffering dehydration due to acute gastroenteritis. If ondansetron further reduces the incidence of vomiting compared with intravenous fluid alone, more children with dehydration due to acute gastroenteritis may be successfully discharged to home from the emergency department instead of admitted to the hospital. If it does not, the widespread use of ondansetron for such patients could be discouraged and money could be saved.

Hypothesis:

Patients receiving ondansetron in addition to intravenous fluids for the treatment of dehydration due to vomiting caused by gastroenteritis will not have a significant reduction in the occurrence of persistent vomiting as compared to those who receive only intravenous fluids.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
2	Placebo Comparator	Saline	Drug: Saline
1	Active Comparator	Zofran	Drug: Ondansetron

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ondansetron	Drug		1
Saline

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Received further IV fluids		2-7 days post discharge

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 6 months - 5 years
Clinical diagnosis of acute gastroenteritis
Mild or moderate dehydration as determined by validated clinical scale
Clinical assessment to begin IV fluids
Vomiting ≥ 2 episodes in past 4 hours

Exclusion Criteria:

Severe dehydration
History of significant gastrointestinal, metabolic, renal or cardiac disorder
Ondansetron allergy
Non-English language proficient parent/guardian
Parent/guardian has no telephone

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam Reid, MD	Children's Hospitals and Clinics of Minnesota	Principal Investigator
Henry Ortega, MD	Children's Hospitals and Clinics of Minnesota	Principal Investigator
Jeffrey Louie, MD	Children's Hospitals and Clinics of Minnesota	Principal Investigator

Locations

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16625009	Background	Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
11927735	Background	Reeves JJ, Shannon MW, Fleisher GR. Ondansetron decreases vomiting associated with acute gastroenteritis: a randomized, controlled trial. Pediatrics. 2002 Apr;109(4):e62. doi: 10.1542/peds.109.4.e62.

ID	Term
D014883	Water-Electrolyte Imbalance
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D010335	Pathologic Processes

ID	Term
D017294	Ondansetron
D012965	Sodium Chloride

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

ID	Term
D003681	Dehydration
D005759	Gastroenteritis