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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03209674
Recruitment Status : Recruiting
First Posted : July 6, 2017
Last Update Posted : April 3, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Heart Diseases Death Postoperative Complications Cardiac Complication Procedure: Cardiothoracic surgery

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 8000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Months
Official Title: Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
Actual Study Start Date : January 1, 2012
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Intervention Details:
  • Procedure: Cardiothoracic surgery
    Cardiac or thoracic procedure


Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing cardiac or thoracic surgery in CMC Ambroise Paré
Criteria

Inclusion Criteria:

  • all patients eligible for cardiac or thoracic surgery

Exclusion Criteria:

  • non applicable

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209674


Contacts
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Contact: Alain Brusset, MD brusseta@club-internet.fr
Contact: Lee S Nguyen, MD nguyen.lee@icloud.com

Locations
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France
CMC Ambroise Paré Recruiting
Neuilly-sur-Seine, Ile-de-France, France, 92200
Contact: Marie-Caroline Merand       marie-caroline.merand@clinique-a-pare.fr   
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
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Study Chair: Marie-Caroline Merand CMC Ambroise Paré
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03209674    
Other Study ID Numbers: RIPOSTE
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: non-applicable.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CMC Ambroise Paré:
Cardiac surgery
Thoracic surgery
Additional relevant MeSH terms:
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Heart Diseases
Postoperative Complications
Cardiovascular Diseases
Pathologic Processes