Effect of Chronic Oral Hydration in Patients With Recurre... | NCT00143754

Studies
Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope

NCT00143754

Sponsor

University Hospital, Angers

Status

Terminated

Last Update Posted

Sep 2, 2005Estimated

Enrollment

Not provided

Phase

Phase 3

Conditions

Hydration
Loss of Consciousness
Neurocardiogenic Syncope

Interventions

Hydration

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

ID	Type	Description	Link
Centre Evian pour l'Eau

Status Module

Record Verification Date

Aug 2005

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Aug 31, 2005

First Submission Date that Met QC Criteria

Aug 31, 2005

First Posted Date

Sep 2, 2005Estimated

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

Aug 31, 2005

Last Update Posted Date

Sep 2, 2005Estimated

Description Module

Brief Summary

Beneficial effect of chronic hydration with salt supplementation in patients with recurrent unexplained syncope is not established. We sought to determine if chronic oral rehydration with salt supplementation improved the tolerance and hemodynamic responses of patients with unexplained recurrent syncope.

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

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Hydration	Procedure

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Syncopal and/or near syncopal episodes at least twice within the prior 3 months

Exclusion Criteria:

Neurological disease
Structural heart disease
Metabolic and psychiatric illness

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Georges PN Leftheriotis, MD-PhD	HUAngers	Principal Investigator

Condition Browse Module

MeSH Terms

ID	Term
D014474	Unconsciousness
D019462	Syncope, Vasovagal

Ancestor Terms

ID	Term
D003244	Consciousness Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided