Stroke Volume VariationNCT00447200
Study of the Natural Variation in Strokevolume
An observational study of Stroke Volume Variation, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stroke Volume Variation
- What is being tested?
- Esophagus Doppler monitoring and Fluid optimization
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2007to Aug 2007
- Phase
- Observational
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Planned abdominal surgery
Who cannot join
- Oesophageal pathology,
- Age >90 yr or <18 yr,
- Alcohol abuse,
- Aneurism in thoracic aorta
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler
We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.
Read the detailed description
We would like to investigate the natural variation in the strokevolume(SV) of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.
Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.
- Conditions
- Stroke Volume Variation
- Being tested
- Esophagus Doppler monitoring, Fluid optimization
- Keywords
- Stroke volume, SV variation, Esophagus Doppler, Goal Directed Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagus Doppler monitoringProcedure or surgery
Fluid optimizationProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Strokevolume variation before fluid optimization
Strokevolume variation after fluid optimization
Number of cycles needed in order to detect a 10% strokevolume increase after fluid bolus of 200ml Voluven.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startMar 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke Volume VariationStudies 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Investigators
- Christoffer Jorgensen, M.S, Principal investigator, Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447200
- Sponsor's protocol ID
- Validation of cycles
- Status last verified
- Oct 2007
- First submitted
- 13 Mar 2007
- Last updated
- 15 Oct 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Natural Variation in Strokevolume, and Investigation in the Number of Cycles Necessary to Find a 10% Strokevolume Variation Using Esophageal Doppler
- ClinicalTrials.gov ID
- NCT00447200
- Acronym / sponsor ID
- Validation of cycles
- Conditions
- Stroke Volume Variation
- Keywords
- Stroke volume, SV variation, Esophagus Doppler, Goal Directed Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Mar 2007
- Study completion
- Aug 2007 (actual)
- First posted
- 14 Mar 2007 (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.
We would like to investigate the natural variation in the strokevolume of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in strokevolume, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.
Detailed description
We would like to investigate the natural variation in the strokevolume(SV) of the heart. At the same time we would like to find out the minimal number of heart cycles necessary to discover a 10% increase in SV, after a fluid bolus of 200ml Voluven, when using Esophageal Doppler.
Also we will compare the variation in SV both before and after the patients have been fluid optimized, using an algorithm of 10% increase in SV in order to receive another fluid bolus. The equipment used, will be the CardioQ from Deltex medical.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned abdominal surgery
Key exclusion criteria (4 listed)
- Oesophageal pathology,
- Age >90 yr or <18 yr,
- Alcohol abuse,
- Aneurism in thoracic aorta
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 |
|---|---|---|
| Esophagus Doppler monitoring | Procedure or surgery | – |
| Fluid optimization | Procedure or surgery | – |
Primary outcome
Strokevolume variation before fluid optimization
Strokevolume variation after fluid optimization
Number of cycles needed in order to detect a 10% strokevolume increase after fluid bolus of 200ml Voluven.
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 15 Oct 2007.
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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.
Christoffer Jorgensen, M.S principal investigator
Dept of anesthesia 2041, ABD centre, Rigshospitalet, Blegdamsvej
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke Volume Variation, 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 4 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 15 Oct 2007. 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?
Strokevolume variation before fluid optimization. The study lists 3 primary outcomes in all. 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 15 Oct 2007.