A Multicenter, Prospective, Randomized, Clinical Trial Comparing Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 440
- 试验地点
- 7
- 主要终点
- Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Treatment assignments will be performed in a blinded manner according to a blocked randomization scheme with a block size of ten, stratified according to the participating center.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants aged ≥60 years with the indication of myocardial revascularization with ≥2 criteria of frailty by Fried Frailty Criteria, and suitable to undergo either Off-pump or On-pump CABG.
排除标准
- •Patients with the indication of angioplasty or another procedure in addition to CABG; patients who underwent an emergency operation (within 24 hours after hospital admission); patients who underwent previous cardiac surgery, even with other approaches than median sternotomy; patients who do not have free, prior and informed consent to participate in this study.
研究组 & 干预措施
Off-pump coronary-artery bypass grafting - OPCAB
Pre-frail and frail patients will be randomly assigned to OPCAB after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.
干预措施: Off-pump coronary-artery bypass grafting (Other)
On-pump coronary-artery bypass grafting - CABG
Pre-frail and frail patients will be randomly assigned to CABG after the evaluation of the target vessels by an internet-based, password protected database program. The surgery will be performed as described in the "intervention" section and the patients will be followed up for two years.
干预措施: On-pump coronary-artery bypass grafting (Other)
结局指标
主要结局
Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients
时间窗: 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
次要结局
- 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)