Off-pump Versus On-pump Coronary Artery Bypass Grafting in Frail Patients
- Conditions
- Frail ElderlyCoronary Artery Disease
- Interventions
- Procedure: On-pump coronary-artery bypass graftingProcedure: Off-pump coronary-artery bypass grafting
- Registration Number
- NCT02338947
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 440
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description On-pump coronary-artery bypass grafting - CABG On-pump coronary-artery bypass grafting 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. Off-pump coronary-artery bypass grafting - OPCAB Off-pump coronary-artery bypass grafting 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.
- Primary Outcome Measures
Name Time Method Major adverse cardiac and cerebrovascular events after OPCAB and CABG in pre-frail and frail patients 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 Outcome Measures
Name Time Method Operative time From the start of anesthesia induction to the end of the surgical procedure Operative time in minutes
Mechanical ventilation time From the initiation of mechanical ventilation in the operating room or ICU to the time of successful extubation Mechanical ventilation time in hours
Hyperdynamic shock From the date of surgery until 30 days postoperatively, assessed up to 30 days A cluster of symptoms that signals the onset of septic shock, often including a shaking chill, rapid rise in temperature, flushing of the skin, galloping pulse, and alternating rise and fall of the blood pressure
New onset of atrial fibrillation From the date of surgery until 30 days postoperatively, assessed up to 30 days 12-lead electrocardiography (ECG) to confirm the diagnosis of new onset atrial fibrillation.
Need for pacing >24 hours From the date of surgery until 30 days postoperatively, assessed up to 30 days Patient who requires pacing \>24 hours
Renal replacement therapy From the date of surgery until 30 days postoperatively, assessed up to 30 days Any type of renal replacement therapy in a patient who does not make continued use of this
Pneumonia From the date of surgery until 30 days postoperatively, assessed up to 30 days Physician or advanced practitioner documents the diagnosis in the medical record based on laboratory findings (e.g. positive sputum culture results from transtracheal fluid and/or bronchial washings) and/or radiological evidence (e.g. chest radiograph diagnostic of pulmonary infiltrates)
Length of stay in intensive care unit From the date of surgery until ICU discharge, assessed up to 30 days Total time in hours in Intensive Care Unit
Length of stay in hospital From the date of surgery until hospital discharge, assessed up to 90 days Total time in days in hospital
Transfusion requirement From the date of surgery until 30 days postoperatively, assessed up to 30 days Number of units of red blood cells transfused
Recurrence of angina From the date of surgery until 30 days postoperatively, assessed up to 30 days To analyse patient recurrence of angina according to the Canadian Cardiovascular Society (CCS)
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 To evaluate and compare the rate of complete revascularization in each of the two strategies. Complete revascularization is defined as targeting arteries larger than 1.5 mm, with stenosis greater than 70%, and a good distal bed
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 Frailty status will be assessed based on the Fried Frailty Criteria, which includes five components: unintentional weight loss, exhaustion, weakness (grip strength), slowness (gait speed), and low physical activity. Patients will be categorized as robust (0 criteria), pre-frail (1-2 criteria), or frail (3-5 criteria) at baseline and at follow-up. Changes in frailty status over time will be evaluated to determine progression, stability, or improvement
Trial Locations
- Locations (7)
Emory University School of Medicine
🇺🇸Atlanta, Georgia, United States
Hospital de Messejana
🇧🇷Fortaleza, Ceará, Brazil
Hospital das Clínicas Samuel Libânio
🇧🇷Pouso Alegre, Minas Gerais, Brazil
Hospital Alberto Urquiza Wanderley
🇧🇷João Pessoa, Paraiba, Brazil
Instituto Nacional de Cardiologia de Laranjeiras
🇧🇷Rio De Janeiro, Brazil
Beneficência Portuguesa de São Paulo
🇧🇷São Paulo, Brazil
Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina de São Paulo
🇧🇷São Paulo, Brazil