Hemodynamic MonitoringstandartNCT02156856
Stroke Volume Analysis During Aortic Valve Replacement Trial
An observational study of Hemodynamic Monitoring and Cardiac Output, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodynamic Monitoring, Cardiac Output, Cardiac Surgery
- How many people
- 68 participants
- Where
- 1 siteGermany
- Study dates
- May 2014to May 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac surgery at a university hospital
Who may be able to join
- scheduled transcatheter aortic valve implantation
- signed patient consent form
- aged 18 or older by time of surgery
- no participation in other clinical trials
Who cannot join
- pregnant or breast-feeding women
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charité Universitätsmedizin Berin
Berlin, State of Berlin, 10117
Michael Sander, MD, +4930450531052, michael.sander@charite.de
Sascha Treskatsch, MD
About this study
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.
- Conditions
- Hemodynamic Monitoring, Cardiac Output, Cardiac Surgery
- Keywords
- hemodynamic monitoring, cardiac output, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hemodynamic optimisation | Not described | |
| No hemodynamic optimisation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Measured: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Measured: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Secondary outcomes (4)
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Measured: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
Measured: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
Measured: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Measured: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic MonitoringStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02156856
- Sponsor's protocol ID
- EA1/060/13
- Acronym
- standart
- Status last verified
- Aug 2014
- First submitted
- 20 May 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke Volume Analysis During Aortic Valve Replacement Trial
- ClinicalTrials.gov ID
- NCT02156856
- Acronym / sponsor ID
- standart / EA1/060/13
- Conditions
- Hemodynamic Monitoring, Cardiac Output, Cardiac Surgery
- Keywords
- hemodynamic monitoring, cardiac output, cardiac surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2015 (estimated)
- First posted
- 5 Jun 2014 (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.
Compromised peripheral tissue oxygenation during surgery may lead to worse patient outcome, mainly due to post-operative infections or heart failure. Insufficient stroke volume and/or cardiac output due to hypovolemia or cardiac defects play a central role in causing poor peripheral tissue oxygenation. In order to assess stroke volume, there are numerous invasive and non-invasive methods available. Up to the present date it is unknown, if these methods may by used interchangeably in patients with severe cardiac defects like aortic stenosis.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemodynamic optimisation | – | – |
| No hemodynamic optimisation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac surgery at a university hospital
Key inclusion criteria (4 listed)
- scheduled transcatheter aortic valve implantation
- signed patient consent form
- aged 18 or older by time of surgery
- no participation in other clinical trials
Key exclusion criteria (2 listed)
- pregnant or breast-feeding women
- emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Time frame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter
Time frame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
4 secondary outcomes
Measurement of stroke volume (ml) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Time frame: After surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter AFTER ADMINISTRATION OF FLUID BOLUS
Time frame: Before and after surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Accordance of stroke volume and cardiac output measurements assessed by two of the mentioned methods [i.e. (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter]
Time frame: Before and after Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Measurement of cardiac output (l/min) after TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography and (3) pulmonary thermodilution via pulmonary artery catheter
Time frame: After Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2014.
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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.
Michael Sander, MD principal investigator
Charite University, Berlin, Germany
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 Hemodynamic Monitoring and Cardiac Output, run by Charite University, Berlin, Germany at 1 site in Germany.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 8 Aug 2014. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Sander, MD (+4930450531052, michael.sander@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of stroke volume (ml) before TAVI (transcatheter aortic valve implantation) by means of (1) FloTrac, (2) transesophageal doppler echocardiography, (3) pulmonary thermodilution via pulmonary artery catheter (time frame: Before Surgery; participants will be followed for the duration of hospital stay, an expected average of 2 weeks). The study lists 2 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 8 Aug 2014.