A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Frail Elderly
- Sponsor
- University of Sao Paulo General Hospital
- Enrollment
- 440
- Locations
- 7
- Primary Endpoint
- Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
Frailty is defined as a geriatric syndrome of impaired resiliency to stressors (such as cardiac surgery) that has been delineated recently in the cardiovascular literature. One of the most controversial areas of cardiac surgery has been whether off-pump coronary artery bypass grafting (OPCAB) surgery is superior to conventional on-pump coronary artery bypass grafting (CABG) surgery. There is an ongoing debate about the benefits and disadvantages of OPCAB surgery and we believe that this remains an important technique for the improvement of coronary surgery. The benefits of CABG surgery in frail patients are still undetermined. The aim of this study is to clarify the potential benefit of OPCAB surgery in pre-frail and frail patients by comparing off-pump versus on-pump CABG in these patients.
Detailed Description
The FRAGILE protocol is a national multicenter randomized controlled trial (RCT), conducted in 6 Brazilian institutions. The study is already approved by a certified ethics committee. Funding is provided by a grant from São Paulo Research Foundation (FAPESP), which otherwise will not have any role in the conduct of the study nor in the analysis nor in the reporting of data. A confidentiality agreement regarding data use and the data safety will be monitored by an independent monitoring board. All the authors will provide revisions and comments and be testifying for the accuracy and completeness of the report, as well as for the fidelity of the report to the study protocol.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
Time Frame: From the date of surgery until 30 days postoperatively, assessed up to 30 days
This composite outcome comprises: all cause death, acute myocardial infarction, stroke, renal failure, acute respiratory distress syndrome and bleeding reoperation
Secondary Outcomes
- Operative time(From the start of anesthesia induction to the end of the surgical procedure)
- Mechanical ventilation time(From the initiation of mechanical ventilation in the operating room or ICU to the time of successful extubation)
- Hyperdynamic shock(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- New onset of atrial fibrillation(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Need for pacing >24 hours(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Renal replacement therapy(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Pneumonia(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Length of stay in intensive care unit(From the date of surgery until ICU discharge, assessed up to 30 days)
- Length of stay in hospital(From the date of surgery until hospital discharge, assessed up to 90 days)
- Transfusion requirement(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Recurrence of angina(From the date of surgery until 30 days postoperatively, assessed up to 30 days)
- Rate of complete revascularization(Assessed at the end of the surgical procedure, evaluated within the intraoperative period, with an estimated duration of up to 600 minutes)
- Evolution of frailty status(From the date of hospital discharge until 6 months postoperatively and from the date of hospital discharge until 12 months postoperatively, assessed up to 1 year)