Cardiac Surgery With Extracorporeal CirculationNCT02132871
Preload Dependency by Impedance Cardiography After Cardiac Surgery
An observational study of Cardiac Surgery With Extracorporeal Circulation, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery With Extracorporeal Circulation
- What is being tested?
- Impedance cardiography Physioflow ®
- Type of treatment
- Medical device
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to May 2016
- 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: Patients requiring cardiac surgery
Who may be able to join
- Men or women over 18 years
- Affiliated to a social protection
- Signed written consent
- Informed about the results of the medical visit
- All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
- Sedated and under mechanical ventilation
Who cannot join
- Cardiac arrhythmia
- Contraindication to PLR maneuver
- Exclusion period due to inclusion in a previous or ongoing study
- Impossibility to provide enlightened information
- Patient deprived of liberty, under judicial protection, trusteeship or guardianship
- Pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'Anesthésiologie, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery
The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.
- Being tested
- Impedance cardiography Physioflow ®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impedance cardiography Physioflow ®Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Not described Receives: Device: Impedance cardiography Physioflow ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR
Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or < 12%
Measured: Within the 6 first hours after cardiac surgery
Secondary outcomes (2)
Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)
Measured: Within the 6 first hours after cardiac surgery
Respiratory variation of inferior vena cava
Measured: Within the 6 first hours after cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startMay 2014
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac Surgery With Extracorporeal CirculationStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nassim HESHMATI, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132871
- Sponsor's protocol ID
- 5516
- Status last verified
- Aug 2016
- First submitted
- 5 May 2014
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Assessment of Preload Dependency by Passive Leg Raising Test and Impedance Cardiography Compared to Echocardiographic Measurements After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02132871
- Acronym / sponsor ID
- 5516
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 7 May 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.
The primary purpose of this study is to investigate wether the measure of stroke volume (SV) variations by impedance cardiography during passive leg raising (PLR) can reliably predict preload dependency after cardiac surgery, in comparison to a reference parameter : velocity time integral (VTI) variation measured by transthoracical echocardiography.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Impedance cardiography Physioflow ® |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring cardiac surgery
Key inclusion criteria (6 listed)
- Men or women over 18 years
- Affiliated to a social protection
- Signed written consent
- Informed about the results of the medical visit
- All type of cardiac surgery with extracorporeal circulation performed at University Hospital of Strasbourg
Key exclusion criteria (6 listed)
- Cardiac arrhythmia
- Contraindication to PLR maneuver
- Exclusion period due to inclusion in a previous or ongoing study
- Impossibility to provide enlightened information
- Patient deprived of liberty, under judicial protection, trusteeship or guardianship
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 |
|---|---|---|
| Impedance cardiography Physioflow ® | Device | 1 |
Primary outcome
Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR
Time frame: Within the 6 first hours after cardiac surgery
Patients classified as responders and non responders to PLR : VTI variation ≥ 12% or < 12%
2 secondary outcomes
Variation of central veinous pressure, left auricular pressure and left ventricular filling pressures after PLR (ROC curves, correlation tests)
Time frame: Within the 6 first hours after cardiac surgery
Respiratory variation of inferior vena cava
Time frame: Within the 6 first hours after cardiac surgery
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 9 Aug 2016.
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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.
Nassim HESHMATI, MD principal investigator
Hôpitaux Universitaires de Strasbourg
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 Cardiac Surgery With Extracorporeal Circulation, run by University Hospital, Strasbourg, France at 1 site in France.
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 6 inclusion and 6 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 9 Aug 2016. 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 France. 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?
Area under ROC curve comparing SV variation (impedance cardiography) and VTI variation after PLR (time frame: Within the 6 first hours after cardiac surgery). 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 9 Aug 2016.