Comparison of Individualized vs Standard Blood Pressure Target on the Postoperative Myocardial Injury in High Risk Patients Undergoing Non-cardiac Surgery- a Randomized Non-inferiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 1
- 主要终点
- Occurrence of postoperative myocardial injury
研究概览
简要总结
This study compares the effect of individualized vs standard blood pressure management on postoperative myocardial injury in high-risk patients undergoing non-cardiac surgery by measuring the hs-cTnT levels. Continuous norepinephrine infusion is used to target a mean pressure of greater than 65mmHg and a systolic pressure less than 160mmHg in the standardized group while the target is 20% within the ward blood pressure in the individualized group. The pre- and postoperative hs-cTnT levels to detect myocardial injury are compared between the two groups.
详细描述
Managing the blood pressure preoperatively is important in high-risk patients because hypotension can lead to perioperative myocardial injury. It has been reported that a systolic pressure of less than 50-55mmHg or greater than 40% decrease can lead to cardiac complications. The mechanism of hypotension leading to postoperative myocardial injury is due to hypoperfusion and ischemic reperfusion injury.
In this randomized controlled study, the blood pressure for participants in the standardized group is maintained as follows: mean blood pressure greater than 65mmHg and systolic blood pressure less than 160mmHg. The individualized group participants' blood pressure is maintained at a target of 20% within the preoperative ward blood pressure. Anesthesia and intraoperative management are the same in both groups to target a bispectral index level of 50. In order to quantitatively measure the myocardial injury, high sensitive cardiac troponin T (hs-cTnT) will be measured pre- and postoperatively. A level greater than 14ng/dl has been reported to be associated with myocardial injury and mortality. The objective of this study is to show that the standardized protocol of maintaining a mean pressure greater than 65mmHg is non inferior to the individualized management in terms of postoperative myocardial injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for general or urologic surgeries under general anesthesia at Seoul National University Hospital
- •high-risk patients with a revised cardiac risk index of at least 2 points or more
排除标准
- •severely uncontrolled hypertension (systolic blood pressure ≥ 180mmHg or mean blood pressure ≥ 110)
- •severely uncontrolled hypotension (systolic blood pressure < 80mmHg)
- •arrhythmias with symptoms or use of pacemaker
- •transplantation surgery
- •acute or decompensated heart failure
- •acute coronary syndrome
- •end stage renal disease (GFR <30ml/min/1.73m2)
- •contraindications of norepinephrine infusion
结局指标
主要结局
Occurrence of postoperative myocardial injury
时间窗: baseline and postoperative day 1
the change of hs-cTnT levels
次要结局
- hospital LOS(1 month)
- ICU LOS(1 month)
- acute myocardial complications(1 month)
- Amount of norepinephrine used(intraoperative)
- intraoperative vital signs(intraoperative)
- acute kidney injury(postoperative 48 hours)
- in hospital mortality(1 month)
研究者
Chul-Woo Jung
Associate Professor
Seoul National University Hospital