2023-508255-39-00招募中3 期
The effect of noradrenaline infusion versus standard blood pressure management on perioperative HYPotension in NOncaRdiac surgery.
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 750
- 试验地点
- 6
- 主要终点
- The primary outcome is perioperative hypotension, defined as any mean arterial pressure (MAP) reading ≤55 mmHg during and up to 4 hours after noncardiac surgery.
研究概览
简要总结
The study aims to determine whether perioperative noradrenaline infusion is superior to standard blood pressure management for the occurrence of perioperative hypotension in patients having noncardiac surgery.
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
- •≥45years old
- •Elective or accelerated* for noncardiac surgery expected to last ≥ 1 hour and requiring general, neuraxial, or combined general & neuraxial anaesthesia
- •Expected to require at least overnight hospital stay
- •Written informed consent to participate in the HYP-NOR Trial provided
- •American Society of Anesthesiologists (ASA) physical status class II or higher.
排除标准
- •Newly diagnosed, untreated, or uncontrolled hypertension -in two measurements on the day before surgery Systolic Blood Pressure (SBP) ≥180 mm Hg or Diastolic Blood Pressure (DBP) ≥110 mm Hg
- •Receiving irreversible nonselective monoamine oxidase inhibitors (e.g. tranylcypromine, phenelzine) within 2 weeks preceding study enrolment
- •Have contraindications to noradrenaline per clinician judgement
- •Noradrenaline infusion started before surgery or plan to use continuous noradrenaline infusion throughout the procedure
- •Treating physician (surgeon/anaesthetist) decides on the necessity of extended continuous hemodynamic monitoring during or after surgery
- •Severe kidney disease (MDRD creatinine clearance <15 mL/min/1.73m2) or renal replacement therapy
- •Persistent difference in recorded SBP between right and left upper limb >10 mm Hg
- •Persistent atrial fibrillation
- •End-stage heart failure
- •Known severe liver disease
- •Emergency and urgent surgery defined as performed within 24 hours of sudden illness/unplanned admission to hospital
- •Have previously participated in the trial
- •Pregnant or breastfeeding women
- •Have a documented history of dementia
- •Have language, vision, or hearing impairments that may compromise cognitive assessments
- •Have a condition that precludes routine blood pressure management such as surgeon request for relative hypotension
结局指标
主要结局
The primary outcome is perioperative hypotension, defined as any mean arterial pressure (MAP) reading ≤55 mmHg during and up to 4 hours after noncardiac surgery.
The primary outcome is perioperative hypotension, defined as any mean arterial pressure (MAP) reading ≤55 mmHg during and up to 4 hours after noncardiac surgery.
次要结局
- Secondary outcomes include time under MAP ≤60 mm Hg intraoperatively and postoperatively; a composite of major perfusion-related complications: myocardial injury after noncardiac surgery (MINS), acute kidney injury (AKI), stroke, non-fatal cardiac arrest, sepsis, and death of all causes; infusion-related reactions; days alive and at home up to 30 days after surgery.
研究者
Wojciech Szczeklik
Scientific
Uniwersytet Jagiellonski Collegium Medicum
研究点 (6)
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