Prevention of Myocardial Injury by Remote Ischemic Preconditioning in Emergent or Urgent Non-cardiac Surgery: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 573
- 试验地点
- 6
- 主要终点
- Number of patients with myocardial injury in non-cardiac surgery
研究概览
简要总结
Worldwide, more than 200 million patients have major non-cardiac surgery annually and a significant proportion of these patients suffer major cardiovascular complications (e.g. nonfatal myocardial infarction, cardiac arrest, vascular death) within 30 days of their surgery. Perioperative myocardial infarction is the most common cardiovascular complication and recent clinical studies have shown that even minor myocardial injury in relation to non-cardiac surgery is associated with 30-day mortality.
Remote ischemic preconditioning is a procedure, which protects remote tissues and organs e.g. against ischemia-reperfusion injury. Cycles of forearm or leg ischemia and reperfusion by the inflation of a blood-pressure cuff for brief periods are the preferred method.The aim of this interventional clinical study is to determine whether remote ischemic preconditioning can reduce markers of myocardial injury in emergent or urgent non-cardiac surgery.
详细描述
Patients with a hip fracture will be included in the study. The patients will be randomized to remote ischemic preconditioning or control (no intervention). The remote ischemic preconditioning procedure is carried out immediately after the induction of regional or general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is carried out 4 times in a row. For patients with systolic blood pressures >185 mmHg, the cuff will be inflated to at least 15 mmHg above the patient's systolic blood pressure.
The primary outcome is myocardial injury in noncardiac surgery within day 4 postoperatively.
We expect 15% of the patients in the placebo group to suffer myocardial injury while the incidence of myocardial injury is expected to be reduced to 7% in the intervention group. Type I error is set at 5% and type II error is set at 20%. In total 2 x 264 patients need to be included based on this power calculation. We will include patients until we have a total of 2 x 270 patients for evaluation (per-protocol).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥ 45 years undergoing in-hospital hip fracture surgery
- •undergoing emergent or urgent surgery (i.e. emergent or urgent visitation to the Department of Orthopedic Surgery)
- •fulfil 1 or more of the following 4 inclusion criteria, which are all determined during the conversation with the patient:
- •Ischemic heart disease, defined by any of the following criteria A. angina pectoris B. prior myocardial infarction C. prior percutaneous coronary intervention D. prior coronary artery bypass graft
- •Peripheral arterial disease, defined by any of the following criteria A. intermittent claudication B. reduced peripheral arterial blood flow C. prior vascular surgery due to peripheral arterial disease
- •Prior stroke OR
- •any 1 of 7 risk criteria A. age ≥70 years; B. congestive heart failure C. prior transient ischemic attack; D. diabetes and currently taking an oral hypoglycemic agent or insulin E. hypertension G. preoperative serum creatinine >175 µmol/L (>2.0 mg/dl) H. smoking within 2 years of surgery
排除标准
- •History of peripheral arterial disease affecting both upper limbs
- •Renal failure with eGRF<30ml/min/1.73m2
- •Cardiogenic shock or cardiac arrest during the current hospital admission
- •Reoperation after elective surgery carried out during the current hospital admission
- •Not capable of giving informed consent after oral and written information
- •Other conditions that prevent the performance of remote ischemic preconditioning.
- •Previously included in this trial
研究组 & 干预措施
Intervention
Remote ischemic preconditioning, 4 cycles of 5 minutes ischemia and 5 minutes reperfusion of the forearm before surgery.
干预措施: Remote ischemic preconditioning (Procedure)
Control
结局指标
主要结局
Number of patients with myocardial injury in non-cardiac surgery
时间窗: during surgery or the first 4 days after surgery
次要结局
- Endothelial dysfunction (reactive hyperemia index)(24 hours after surgery)
- Peak plasma TnI and total TnI release (area under the curve)(during surgery or the first 4 days after surgery)
- Perioperative myocardial infarction(30 days, one year and 5 years after surgery)
- Major adverse cardiovascular events(30 days, one year and 5 years after surgery)
- Length of postoperative hospital stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- All-cause mortality(30 days, one year and 5 years after surgery)
- Length of intensive care unit stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Biomarkers of coagulation(preoperatively, 2 hours after incision, and on days 1 and 2 after surgery)
- Plasma N-terminal Pro-Brain Natriuretic Peptide(Preoperative and day 1)
研究者
Sarah Victoria Ekeløf Busch
MD, Ph.d. student
Zealand University Hospital