Heart DiseasesRIPOSTENCT03209674
Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
An observational study of Heart Diseases and Death, run by CMC Ambroise Paré at 1 site in France.
Trial summary
The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Diseases, Death, Postoperative Complications
- What is being tested?
- Cardiothoracic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 8,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2012to 31 Dec 2030
- How long will I take part?
- 2 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré
Who may be able to join
- all patients eligible for cardiac or thoracic surgery
Who cannot join
- non applicable
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alain Brusset, MD contact
Lee S Nguyen, MD contact
France1 site, 1 recruiting
- Recruiting
CMC Ambroise Paré
Neuilly-sur-Seine, Île-de-France Region, 92200
Marie-Caroline Merand, marie-caroline.merand@clinique-a-pare.fr
About this study
The registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.
Read the detailed description
Cardiac and thoracic surgery is plagued by severe morbidity and mortality. Understanding and being able to predict postoperative outcomes may allow to better fit peri-operative care of cardio-thoracic patients.
RIPOSTE database aims to prospectively collect baseline characteristics and per-operative information in order to test associations with the incidence of postoperative outcomes.
Baseline characteristics include: age, EuroSCORE 2 and its components (age, gender, New York Heart Association (NYHA) functional class, angina symptoms, insulin-dependent diabetes mellitus, extracardiac arteriopathy, chronic pulmonary dysfunction, neurological or musculoskeletal dysfunction severely affecting mobility, previous cardiac surgery, renal function with creatinin clearance, active endocarditis, critical preoperative state, left ventricle ejection fraction, recent myocardial infarction, pulmonary artery systolic pressure, procedure urgency and weight of the procedure (coronary artery bypass graft, valve surgery and/or thoracic aorta)) weight, height, preoperative biology and preoperative echocardiography parameters when measured.
Peroperative information include: cardiac bypass duration, type of procedure, implanted device, valve size.
Postoperative outcomes include: death, postoperative shock, mediastinitis, length of stay in intensive care unit, overall length of stay, blood transfusion.
- Being tested
- Cardiothoracic surgery
- Keywords
- Cardiac surgery, Thoracic surgery
- Medical subject headings
- Heart Diseases, Death, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiothoracic surgeryProcedure or surgery
Cardiac or thoracic procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
death occurring in the same hospital where the operation took place before discharge from the hospital
Measured: During follow-up, until discharge from hospital, up to 1 year.
Secondary outcomes (6)
Postoperative shock
Use of catecholamines (dobutamine, norepinephrine and/or epinephrine) in order to achieve adequate cardiac output (cardiac index > 2.2 l/min/m2), in the first 24 hours after surgery
Measured: In the first 24 hours after surgery
Length of stay in the ICU (days)
length of stay in the intensive care unit after cardiac or thoracic surgery
Measured: During follow-up, until discharge from the ICU, up to 1 year.
Total length of stay (days)
length of stay in the hospital, including preoperative period
Measured: During follow-up, until discharge from the hospital, up to 1 year.
Mediastinitis
Incidence of mediastinitis in the postoperative period
Measured: During follow-up, until discharge from the hospital, up to 1 year.
Redo surgery
Redo surgery after primary surgery
Measured: During follow-up, until discharge from the hospital, up to 1 year.
Pneumoniae
Hospital-acquired or Ventilator-acquired pneumonia as defined by Center for Disease Control guidelines
Measured: During follow-up, until discharge from the hospital, up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2017
- Study start1 Jan 2012
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies 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
- 8,000 participants (estimated)
- Target duration
- 2 Months
Sponsor and investigators
- Lead sponsor
- CMC Ambroise Paré
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Caroline Merand, Study chair, CMC Ambroise Paré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03209674
- Sponsor's protocol ID
- RIPOSTE
- Acronym
- RIPOSTE
- Status last verified
- Apr 2026
- First submitted
- 3 Jul 2017
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: non-applicable.
Publications
Suc G, Estagnasie P, Brusset A, Procopi N, Squara P, Nguyen LS. Effect of BNP on risk assessment in cardiac surgery patients, in addition to EuroScore II. Sci Rep. 2020 Jul 2;10(1):10865. doi: 10.1038/s41598-020-67607-0.
PubMed 32616802
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
- ClinicalTrials.gov ID
- NCT03209674
- Acronym / sponsor ID
- RIPOSTE / RIPOSTE
- Keywords
- Cardiac surgery, Thoracic surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- CMC Ambroise ParéUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Jul 2017 (actual)
- 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 registry for the improvement of postoperative outcomes in cardiac and thoracic surgery aims to prospectively collect data in order to test the association between various preoperative and per-operative variables ; and several postoperative outcomes such as mortality, shock, redo surgery, sepsis and extracorporeal life-support.
Detailed description
Cardiac and thoracic surgery is plagued by severe morbidity and mortality. Understanding and being able to predict postoperative outcomes may allow to better fit peri-operative care of cardio-thoracic patients.
RIPOSTE database aims to prospectively collect baseline characteristics and per-operative information in order to test associations with the incidence of postoperative outcomes.
Baseline characteristics include: age, EuroSCORE 2 and its components (age, gender, New York Heart Association (NYHA) functional class, angina symptoms, insulin-dependent diabetes mellitus, extracardiac arteriopathy, chronic pulmonary dysfunction, neurological or musculoskeletal dysfunction severely affecting mobility, previous cardiac surgery, renal function with creatinin clearance, active endocarditis, critical preoperative state, left ventricle ejection fraction, recent myocardial infarction, pulmonary artery systolic pressure, procedure urgency and weight of the procedure (coronary artery bypass graft, valve surgery and/or thoracic aorta)) weight, height, preoperative biology and preoperative echocardiography parameters when measured.
Peroperative information include: cardiac bypass duration, type of procedure, implanted device, valve size.
Postoperative outcomes include: death, postoperative shock, mediastinitis, length of stay in intensive care unit, overall length of stay, blood transfusion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Months
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré
Key inclusion criteria (1 listed)
- all patients eligible for cardiac or thoracic surgery
Key exclusion criteria (1 listed)
- non applicable
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 |
|---|---|---|
| Cardiothoracic surgeryCardiac or thoracic procedure | Procedure or surgery | – |
Primary outcome
In-hospital mortality
Time frame: During follow-up, until discharge from hospital, up to 1 year.
death occurring in the same hospital where the operation took place before discharge from the hospital
6 secondary outcomes
Postoperative shock
Time frame: In the first 24 hours after surgery
Length of stay in the ICU (days)
Time frame: During follow-up, until discharge from the ICU, up to 1 year.
Total length of stay (days)
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Mediastinitis
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Redo surgery
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Pneumoniae
Time frame: During follow-up, until discharge from the hospital, up to 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Derived from this study: PubMed 32616802Suc G, Estagnasie P, Brusset A, Procopi N, Squara P, Nguyen LS. Effect of BNP on risk assessment in cardiac surgery patients, in addition to EuroScore II. Sci Rep. 2020 Jul 2;10(1):10865. doi: 10.1038/s41598-020-67607-0.
- Individual participant dataSharing planned: No. non-applicable.
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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.
Alain Brusset, MD contact
Lee S Nguyen, MD contact
Marie-Caroline Merand study chair
CMC Ambroise Paré
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 Heart Diseases and Death, run by CMC Ambroise Paré 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 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: looking for participants now, as of the sponsor's last update on 3 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alain Brusset, MD (brusseta@club-internet.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: During follow-up, until discharge from hospital, up to 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03209674, which also lists 1 linked publication.
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 3 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.