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

Heart Diseases Clinical Trial

— RIPOSTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03209674
• Other study ID #: RIPOSTE
• Status: Recruiting
• Start date: January 1, 2012
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2023
• Source: CMC Ambroise Paré
• Contact: Alain Brusset, MD
• Email: brusseta[@]club-internet.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 life-support.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8000
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• all patients eligible for cardiac or thoracic surgery

Exclusion Criteria:

• non applicable

Related Conditions & MeSH terms

• Cardiac Complication
• Death
• Heart Diseases
• Postoperative Complications

Intervention

Procedure:
• Cardiothoracic surgery
Cardiac or thoracic procedure

Locations

Country	Name	City	State
France	CMC Ambroise Paré	Neuilly-sur-Seine	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
CMC Ambroise Paré

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	death occurring in the same hospital where the operation took place before discharge from the hospital	During follow-up, until discharge from hospital, up to 1 year.
Secondary	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	In the first 24 hours after surgery
Secondary	Length of stay in the ICU (days)	length of stay in the intensive care unit after cardiac or thoracic surgery	During follow-up, until discharge from the ICU, up to 1 year.
Secondary	Total length of stay (days)	length of stay in the hospital, including preoperative period	During follow-up, until discharge from the hospital, up to 1 year.
Secondary	Mediastinitis	Incidence of mediastinitis in the postoperative period	During follow-up, until discharge from the hospital, up to 1 year.
Secondary	Redo surgery	Redo surgery after primary surgery	During follow-up, until discharge from the hospital, up to 1 year.
Secondary	Pneumoniae	Hospital-acquired or Ventilator-acquired pneumonia as defined by Center for Disease Control guidelines	During follow-up, until discharge from the hospital, up to 1 year.