2024-517373-25-00招募中4 期
The effect of epinephrine, norepinephrine and phenylephrine on intraoperative hemodynamic performance – a prospective double-blinded randomized clinical trial
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
研究概览
简要总结
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Outcome assessment
- 盲法
- Double (Subject, Investigator, Monitor, Analyst, Carer)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥ 45 years old
- •Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least 2 hours
- •ASA physical status ≥ 2
- •At least one of the following risk factors (a-j): a. Age ≥ 75 years b. History of peripheral arterial disease c. History of coronary artery disease d. History of stroke or transient ischemic attack e. History of chronic kidney disease f. Diabetes requiring medical treatment g. Current smoking or history of 15 pack-years h. History of heart failure i. Preoperative high-sensitivity Troponin T ≥ 14ng.L-1 j. Preoperative NT-proBNP ≥ 200 pg.mL-1
排除标准
- •Scheduled for pheochromocytoma surgery
- •Scheduled for liver and kidney transplantation
- •Requiring preoperative intravenous vasopressor medications
- •Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement
- •Permanent atrial fibrillation
- •Preoperative heart rate >110 bpm
结局指标
主要结局
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
Time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine and phenylephrine.
次要结局
- Secondary outcome 1: Brain regional oxygen saturation (brSO2) – TWA of intraoperative brSO2 values between the groups
- Secondary outcome 2: Tissue regional oxygen saturation (trSO2) – TWA of intraoperative trSO2 values between the groups
研究者
Division of General Anaesthesia and Intensive Care Medicine
Scientific
Medical University Of Vienna
研究点 (1)
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