Impact of Targeted Blood-pressure Management on Incidence of Acute Kidney Injury After Off-pump Coronary Artery Bypass Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 612
- 试验地点
- 1
- 主要终点
- Incidence of acute kidney injury (AKI) within 7 days after surgery
研究概览
简要总结
Acute renal injury (AKI) is a common complication after cardiac surgery and is associated with worse outcomes. It is now realized that intraoperative hypotension is an important risk factor for the development of AKI. In a recent randomized controlled trial of patients undergoing major noncardiac surgery, intraoperative individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. The investigators hypothesize that, for patients undergoing off-pump CABG, targeted blood-pressure management during surgery may also reduce the incidence of postoperative AKI.
详细描述
Acute renal injury (AKI) is a common complication after cardiac surgery. In patients undergoing noncardiac surgery, intraoperative hypotension may lead to hypoperfusion of important organs and result in organ injuries such as AKI, myocardial injury, and stroke. The development of organ injuries is associated with wose outcomes including higher 30-day or even 1-year mortality. In a recent randomized controlled trial, patients undergoing major noncardiac surgery received either individualized (systolic blood pressure [SBP] maintained within 10% of the reference level) or standard (SBP maintained above 80 mmHg or within 40% of the reference level) blood-pressure management strategy during surgery. The results showed that individualized blood-pressure management reduced the incidence of postoperative organ dysfunction. Intraoperative hypotension is very common during off-pump coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that, for patients undergoing off-pump CABG, good blood-pressure management with norepinephrine may also reduce the incidence of postoperative AKI. The purpose of this study is to investigate the effect of targeted blood-pressure management during off-pump CABG surgery on the incidence of postoperative AKI.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 50 years;
- •Scheduled to undergo off-pump CABG surgery.
排除标准
- •Refuse to participate;
- •Untreated or uncontrolled severe hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);
- •Chronic kidney disease with a glomerular filtration rate < 30 ml/min/1.73 m2 or end-stage renal disease requiring renal-replacement therapy;
- •Inability to communicate during the preoperative period because of coma, profound dementia, language barrier, or end-stage disease;
- •Requirement of vasopressors/inotropics to maintain blood pressure before surgery;
- •Second or emergency surgery;
- •Expected survival of less than 24 hours.
研究组 & 干预措施
Targeted blood-pressure management
Prophylactic norepinephrine infusion is started at the beginning of anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher during surgery.
干预措施: Targeted blood-pressure management (Drug)
Routine blood-pressure management
Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.
干预措施: Routine blood-pressure management (Drug)
结局指标
主要结局
Incidence of acute kidney injury (AKI) within 7 days after surgery
时间窗: Up to 7 days after surgery
Development of AKI within 7 days after surgery is diagnosed according to the Kidney Disease Improving Global Outcomes (KDIGO) criteria
次要结局
- Classification of AKI within 7 days after surgery(Up to 7 days after surgery)
- Incidence of delirium within 7 days after surgery(Up to 7 days after surgery)
- Duration of mechanical ventilation after surgery(Up to 30 days after surgery)
- Length of stay in intensive care unit (ICU) after surgery(Up to 30 days after surgery)
- All-cause 30-day mortality(At 30 days after surgery)
- 2-year overall survival after surgery(Up to 2 years after surgery)
- 2-year major adverse cardiovascular event (MACE)-free survival after surgery(Up to 2 years after surgery)
- Incidence of major adverse cardiovascular events (MACEs) within 30 days after surgery(Up to 30 days after surgery)
- Length of stay in hospital after surgery(Up to 30 days after surgery)
- Incidence of non-MACE complications within 30 days after surgery(Up to 30 days after surgery)
- Cognitive function in 1- and 2-year survivors(At the end of the 1st and 2nd years after surgery)
- Quality of life in 1- and 2- year survivors: SF-36(At the end of the 1st and 2nd years after surgery)
研究者
Dong-Xin Wang
Professor and Chairman, Department of Anaesthesiology and Critical Care Medicine
Peking University First Hospital