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NCT Number: NCT03209674

Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry

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.

Recruiting

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

Location status: Recruiting

Location contact

Marie-Caroline Merand

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all patients eligible for cardiac or thoracic surgery

Exclusion criteria

  • non applicable

Treatment and study plan

Cardiothoracic surgery

Procedure

Cardiac or thoracic procedure

Primary outcomes

  1. 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

Secondary outcomes

  1. Postoperative shock

    Time frame: In the first 24 hours after surgery

    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

  2. Length of stay in the ICU (days)

    Time frame: During follow-up, until discharge from the ICU, up to 1 year.

    length of stay in the intensive care unit after cardiac or thoracic surgery

  3. Total length of stay (days)

    Time frame: During follow-up, until discharge from the hospital, up to 1 year.

    length of stay in the hospital, including preoperative period

  4. Mediastinitis

    Time frame: During follow-up, until discharge from the hospital, up to 1 year.

    Incidence of mediastinitis in the postoperative period

  5. Redo surgery

    Time frame: During follow-up, until discharge from the hospital, up to 1 year.

    Redo surgery after primary surgery

  6. Pneumoniae

    Time frame: During follow-up, until discharge from the hospital, up to 1 year.

    Hospital-acquired or Ventilator-acquired pneumonia as defined by Center for Disease Control guidelines

Study contacts

Contact information is provided by the study sponsor or research team.

Alain Brusset, MD

CONTACT

[email protected]

Lee S Nguyen, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Acronym: RIPOSTE

Important dates

Study start
2012
Primary completion
2030
Study completion
2030
First posted
Jul 6, 2017
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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