HydrationPhase 3NCT00143754
Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope
A Phase 3 study testing Hydration in people with Hydration and Loss of Consciousness, run by University Hospital, Angers.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hydration, Loss of Consciousness, Neurocardiogenic Syncope
- What is being tested?
- Hydration
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Syncopal and/or near syncopal episodes at least twice within the prior 3 months
Who cannot join
- Neurological disease
- Structural heart disease
- Metabolic and psychiatric illness
About this study
Official title: Benefit of Controlled Rehydration in Unexplained Syncope
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.
- Conditions
- Hydration, Loss of Consciousness, Neurocardiogenic Syncope
- Being tested
- Hydration
- Medical subject headings
- Unconsciousness, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydrationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HydrationStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Investigators
- Georges PN Leftheriotis, MD-PhD, Principal investigator, HUAngers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00143754
- Sponsor's protocol ID
- CP00-02
- Other IDs
- Centre Evian pour l'Eau
- Status last verified
- Aug 2005
- First submitted
- 31 Aug 2005
- Last updated
- 2 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Controlled Rehydration in Unexplained Syncope
- ClinicalTrials.gov ID
- NCT00143754
- Acronym / sponsor ID
- CP00-02
- Conditions
- Hydration, Loss of Consciousness, Neurocardiogenic Syncope
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Lead sponsor
- University Hospital, AngersOther government
- First posted
- 2 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Syncopal and/or near syncopal episodes at least twice within the prior 3 months
Key exclusion criteria (3 listed)
- Neurological disease
- Structural heart disease
- Metabolic and psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hydration | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georges PN Leftheriotis, MD-PhD principal investigator
HUAngers
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hydration in people with Hydration and Loss of Consciousness, run by University Hospital, Angers.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2005.