SyncopeNCT00714766
Heat Stress and Volume Administration
A study testing Intravascular volume administration in people with Syncope, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Syncope
- What is being tested?
- Intravascular volume administration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2008to Aug 2008
- Phase
- Interventional
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age > 18 < 40
Who cannot join
- Abnormal medical history
Trial locations and contacts
1 site in 1 country.
About this study
Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.
- Conditions
- Syncope
- Being tested
- Intravascular volume administration
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular volume administrationProcedure or surgery
Infusion of colloid to reestablish CVP under heat stress
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Procedure: Intravascular volume administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac filling pressure in relation to cardiac SV
Measured: with varying degress of lower body negative pressures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Niels Secher, MD, PhD, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00714766
- Sponsor's protocol ID
- Heat stress RH08
- Status last verified
- Feb 2009
- First submitted
- 10 Jul 2008
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heat Stress and Volume Administration
- ClinicalTrials.gov ID
- NCT00714766
- Acronym / sponsor ID
- Heat stress RH08
- Conditions
- Syncope
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 14 Jul 2008 (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.
Heat stress reduces the central blood volume and causes orthostatic intolerance. The hypothesis is that infusion of volume may reduce effects of orthostatic stress during heat stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Procedure: Intravascular volume administration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age > 18 < 40
Key exclusion criteria (1 listed)
- Abnormal medical history
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 |
|---|---|---|
| Intravascular volume administrationInfusion of colloid to reestablish CVP under heat stress | Procedure or surgery | A |
Primary outcome
Cardiac filling pressure in relation to cardiac SV
Time frame: with varying degress of lower body negative pressures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2009.
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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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.
Niels Secher, MD, PhD study director
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular volume administration in people with Syncope, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 1 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: finished, as of the sponsor's last update on 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
Cardiac filling pressure in relation to cardiac SV (time frame: with varying degress of lower body negative pressures). It is what the study was designed to measure, not a finding.
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 16 Feb 2009.