Heart Diseases Clinical Trial
— RIPOSTEOfficial title:
Registry for the Improvement of Postoperative OutcomeS in Cardiac and Thoracic surgEry
NCT number | NCT03209674 |
Other study ID # | RIPOSTE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2012 |
Est. completion date | December 31, 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | CMC Ambroise Paré | Neuilly-sur-Seine | Ile-de-France |
Lead Sponsor | Collaborator |
---|---|
CMC Ambroise Paré |
France,
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. |
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