Continuous Versus Bolus Norepinephrine Administration to Treat Postinduction Hypotension in High-Risk Non-Cardiac Surgery Patients - The Multicenter INDUCT Trial (INDUCT-Multi)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 446
- 试验地点
- 4
- 主要终点
- Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) (continuous endpoint)
研究概览
简要总结
INDUCT-Multi is a multicenter randomized trial investigating whether continuous, compared to bolus, administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients.
详细描述
Hypotension after induction of general anesthesia, referred to as postinduction hypotension, is common in patients having non-cardiac surgery and is associated with acute kidney injury. Risk factors for postinduction hypotension include older age, higher American Society of Anesthesiologists physical status, chronic arterial hypertension - and higher doses of vasodilating anesthetic drugs. It is reasonable to assume that careful anesthetic management can help maintain blood pressure stability and limit postinduction hypotension. Consistent with this assumption, continuous blood pressure monitoring with an arterial catheter during induction of general anesthesia helps clinicians reduce postinduction hypotension - and is thus recommended in non-cardiac surgery patients at risk for hypotension-related complications.
Besides continuous monitoring, anesthesiologists routinely give vasopressors - such as norepinephrine - to maintain blood pressure. Norepinephrine is a fast acting vasopressor with a short half-life and is usually given as repeated manual boluses during induction of general anesthesia. Given as a bolus, it effectively and rapidly increases blood pressure. However, boluses need to be frequently repeated and well-timed to ensure blood pressure stability.
In a single-center randomized trial, we demonstrated that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia helps maintain blood pressure stability in high-risk non cardiac surgery patients. We now aim to test the hypothesis that continuous - compared to bolus - administration of norepinephrine during induction of general anesthesia reduces postinduction hypotension in high-risk non-cardiac surgery patients who have continuous blood pressure monitoring with an arterial catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will include consenting patients ≥45 years scheduled for elective non-cardiac surgery under general anesthesia with planned continuous intra-arterial blood pressure monitoring with a radial arterial catheter and with at least two of the following risk criteria for developing acute kidney injury:
- •Age ≥65 years
- •ASA physical status III or IV
- •Chronic arterial hypertension
- •Diabetes mellitus requiring medication
- •Intra-abdominal surgery
- •Preoperative renal insufficiency (serum creatinine ≥1.2 mg/dL)
排除标准
- •Pregnancy
- •Cardiac arrhythmia
- •History of intracranial hemorrhage or intracranial aneurysm
- •Clinical indication for continuous norepinephrine infusion during induction of general anesthesia (e.g., severe aortic valve stenosis, coronary artery disease, or heart failure)
- •Patients who are unable to understand, read, and provide informed consent in German
研究组 & 干预措施
Continuous Norepinephrine Administration
In patients assigned to continuous norepinephrine administration, norepinephrine will be administered continuously via a syringe infusion pump.
干预措施: Continuous Norepinephrine Administration (Procedure)
Bolus Norepinephrine Administration
In patients assigned to manual bolus norepinephrine administration, norepinephrine will be given manually in bolus doses.
结局指标
主要结局
Area under a mean arterial pressure (MAP) of 65 mmHg (mmHg x min) (continuous endpoint)
时间窗: First 15 minutes after starting induction of general anesthesia
次要结局
- Area under a MAP of 50 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area under a MAP of 40 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area above a MAP of 100 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area under a MAP of 60 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area above a MAP of 110 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area above a MAP of 120 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Area above a MAP of 140 mmHg (mmHg x min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP <65 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP <60 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP <50 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP <40 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP >100 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP >110 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP >120 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Duration of a MAP >140 mmHg (min) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement <65 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement <60 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement <50 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement <40 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement >100 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement >110 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement >120 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with any MAP measurement >140 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <65 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <60 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <50 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP <40 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >100 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >110 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >120 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Absolute (n) and relative (%) number of patients with at least one 1-minute episode of a MAP >140 mmHg (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
- Cumulative dose of norepinephrine indexed to body weight (µg kg-1) (continuous endpoint)(First 15 minutes after starting induction of general anesthesia)
研究者
Kristen Thomsen
Principal Investigator
Universitätsklinikum Hamburg-Eppendorf