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Recruiting NCT03209674

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

Observational Heart Diseases Death Postoperative Complications Cardiac Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cardiothoracic surgery.
Who it may be relevant to
Registry conditions: Heart Diseases, Death, Postoperative Complications, Cardiac Complication. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Cardiothoracic surgery
    Cardiac or thoracic procedure

Primary outcome measures

  • In-hospital mortality [Time frame: During follow-up, until discharge from hospital, up to 1 year.]
Secondary outcome measures (6)
  • 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.]

Eligibility criteria

Inclusion criteria

  • all patients eligible for cardiac or thoracic surgery

Exclusion criteria

  • non applicable

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CMC Ambroise Paré — Neuilly-sur-Seine

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. PMID 32616802

Identifiers

NCT: NCT03209674 · RIPOSTE

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗