Clinical trial NCT03209674: Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
Official title: Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Heart Diseases
Death
Postoperative Complications
Cardiac Complication
Keywords: Cardiac surgery
Thoracic surgery
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2017-07-06
Enrollment: 8000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* all patients eligible for cardiac or thoracic surgery

Exclusion Criteria:

* non applicable

Primary outcomes:
measure: In-hospital mortality
timeFrame: During follow-up, until discharge from hospital, up to 1 year.
Secondary outcomes:
measure: Postoperative shock
timeFrame: In the first 24 hours after surgery
measure: Length of stay in the ICU (days)
timeFrame: During follow-up, until discharge from the ICU, up to 1 year.
measure: Total length of stay (days)
timeFrame: During follow-up, until discharge from the hospital, up to 1 year.
measure: Mediastinitis
timeFrame: During follow-up, until discharge from the hospital, up to 1 year.
measure: Redo surgery
timeFrame: During follow-up, until discharge from the hospital, up to 1 year.
measure: Pneumoniae
timeFrame: During follow-up, until discharge from the hospital, up to 1 year.
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: CMC Ambroise Paré
state: Ile-de-France
Study officials:
affiliation: CMC Ambroise Paré
name: Marie-Caroline Merand
role: STUDY_CHAIR
References:
citation: 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.