Effects of Norepinephrine Infusion During Cardiopulmonary Bypass on Perioperative Changes in Lactic Acid Level: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Changes in lactic acid level
研究概览
简要总结
The primary objective is to test the efficacy and safety of the accuracy of continuous intravenous infusion of norepinephrine during cardiopulmonary bypass (CPB) on the prevention of hyperlactatemia after cardiac surgery.
"Efficacy" would be tested with measurement of the postoperative changes in lactic acid level over time from the baseline value before induction of general anesthesia.
"safety" would be tested with observing the post-cardiotomy need for inotropic and vasopressor support, the incidence of postoperative acute kidney injury (AKI), changes in cardiac troponin level (CnTnI), and signs of ischemic splanchnic injury.
详细描述
Rationale
1.1. Vasoplegia and cardiac surgery:
Vasoplegia Syndrome (VS), prevailing in about 20% of cardiac surgical procedures (1), is defined as low mean arterial pressure (MAP) with normal or high cardiac indices and which is resistant to treatment with the commonly used vasopressors. (2,3) Vasoplegia might occur either during or after the cardiopulmonary bypass periods or during the postoperative period during the intensive care unit (ICU) stay. (3) Many factors have been found to be related to the increased Vasoplegia during the cardiopulmonary bypass period such as left ventricular ejection fraction more than 40%, male patients, elderly patients, higher body mass index, long cardiopulmonary bypass time, hypotension upon the start of cardiopulmonary bypass, perioperative use of angiotensin-converting enzyme inhibitors (ACE) and presence of infective endocarditis. (4,5)
1.2. Effects of Cardiopulmonary bypass (CPB) on Post cardiotomy Vasoplegia.
Cardiopulmonary bypass itself may intensify the effects of vasoplegia due to hemodilution which decreases the blood viscosity, so, reducing the overall peripheral vascular resistance. Moreover, the interaction of blood with the tubing of the cardiopulmonary bypass machine results in the release of inflammatory mediators which play an important role in reducing the peripheral resistance and aggravating the hypotension. Although compensatory and auto-regulatory mechanisms play an important role in maintaining adequate tissue perfusion, hypotension during the cardiopulmonary bypass period may result in poor outcomes as postoperative stroke (4) especially if the mean arterial pressure is below 65 mmHg. (6)
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)
盲法说明
The placebo and the norepinephrine solutions look identical and their infusions will be continued until 60 min after skin closure. The test solution will be prepared by one anesthesiologist before the induction of anesthesia.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status between ІІІ and ІV
- •Scheduled for any type of elective cardiac surgery using CPB
- •General anesthesia provided in an endotracheally intubated patient.
排除标准
- •Decline consent to participate.
- •Emergency surgery.
- •Ejection fraction (EF%) less than 35%.
- •Scheduled for re-do surgery.
- •Scheduled for emergency surgery.
- •Preoperative ventilator or circulatory support.
- •Body mass index (BMI) greater than 40 Kg/m
- •History of alcohol abuse.
- •History of drug abuse.
- •Pregnancy.
- •Consent for another interventional study during anaesthesia
- •No written informed consent.
研究组 & 干预措施
Norepinephrine
Infusion of norepinephrine (40 µg/ml) will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Increase infusion rate (Other)
Placebo
Infusion of normal Saline 0.9%will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Placebo (Drug)
Placebo
Infusion of normal Saline 0.9%will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Increase infusion rate (Other)
Placebo
Infusion of normal Saline 0.9%will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Decrease infusion rate (Other)
Norepinephrine
Infusion of norepinephrine (40 µg/ml) will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Norepinephrine (Drug)
Norepinephrine
Infusion of norepinephrine (40 µg/ml) will be started following arterial cannulation before initiation of cardiopulmonary bypass and continued until aortic declamping time.
干预措施: Decrease infusion rate (Other)
结局指标
主要结局
Changes in lactic acid level
时间窗: For 24 hours after surgery from the start of surgery
perioperative changes in lactic acid level measured from arterial or venous blood
次要结局
- Postoperative pneumonia(For 30 days after surgery)
- Postoperative hypoxemia(For 30 days after surgery)
- Postoperative sternotomy(For 30 days after surgery)
- Postoperative wound infection(For 30 days after surgery)
- Postoperative mediastinitis(For 30 days after surgery)
- Postoperative stroke(For 30 days after surgery)
- Need for rescue doses of esmolol(For the time of surgery)
- Need for rescue doses of atropine(For the time of surgery)
- Need for rescue doses of glycopyrrolate.(For the time of surgery)
- Intraoperative hypoxemia(For the time of surgery)
- Number of patients who required pacemaker insertion(For the time of surgery)
- Mean Arterial Pressure (MAP)(For 24 hours after surgery from the start of surgery)
- Cardiac Index (CI)(For 24 hours after surgery from the start of surgery)
- Systemic Vascular Resistance index (SVRI)(For 24 hours after surgery from the start of surgery)
- Stroke volume variation (SVV)(For 24 hours after surgery from the start of surgery)
- Need for rescue doses of phenylephrine(For the time of surgery)
- Need for rescue doses of norepinephrine(For the time of surgery)
- Need for rescue doses of ephedrine(For the time of surgery)
- Need for rescue doses of nitroglycerine(For the time of surgery)
- Need for rescue doses of labetalol(For the time of surgery)
- Mortality at 90 days(For 90 days after surgery)
- Postoperative need for reintubation(For 30 days after surgery)
- Postoperative bleeding(For 30 days after surgery)
- Postoperative cardiogenic shock(For 30 days after surgery)
- Postoperative acute kidney injury(For 30 days after surgery)
- Postoperative splanchnic ischemia(For 30 days after surgery)
- Postoperative myocardial ischemia(For 30 days after surgery)
- Postoperative sternal dehiscence(For 30 days after surgery)
- Intraoperative hypercapnia(For the time of surgery)
- Intraoperative hypotension(For the time of surgery)
- Intraoperative bradycardia(For the time of surgery)
- Intraoperative myocardial ischemic episodes(For the time of surgery)
- Number of patients who required direct current shocks(For the time of surgery)
- Hospital Stay(For 30 days after surgery)
- Mortality at 30 days(For 30 days after surgery)
- Number of patients who need for epinephrine(For the time of surgery)
- Number of patients who need for norepinephrine(For the time of surgery)
- Number of patients who need for dobutamine(For the time of surgery)
- Number of patients who need for milrinone(For the time of surgery)
- Number of patients who need for for Intra-Aortic Balloon Pump(For the time of surgery)
- Intraoperative need for blood transfusion(For the time of surgery)
- Intraoperative fluid intake(For the time of surgery)
- ICU Stay(For 30 days after surgery)