The Choice of Vasopressor for Treating Hypotension During General Anesthesia: a Pilot Pragmatic Cluster Cross-over Randomized Trial (the VEGA-1 Trial)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 3,626
- 试验地点
- 10
- 主要终点
- Number of Participants With Assigned Vasopressor Given
研究概览
简要总结
50 million patients undergo surgery each year in the United States. Postoperative mortality is considered the third leading cause of death worldwide. Hypotension during surgery have been linked to increased postoperative morbidity and mortality. Episodes of hypotension during surgery are associated with an increased risk of acute kidney injury, stroke, cardiac events and death. Treating or preventing hypotension during general anesthesia and major surgery was found to improve outcomes. At this time, it is unclear what is the best vasopressor to maintain blood pressure during surgery under general anesthesia. With this pilot pragmatic trial, the investigators will explore the impact of norepinephrine (NE) or phenylephrine (PE) on post-operative events in patients undergoing major surgery with general anesthesia and needing vasopressors infusion to maintain their systemic arterial pressure.
详细描述
Postoperative mortality is considered the third leading cause of death worldwide. Hemodynamic instability and specifically hypotension during surgery have been linked to increased postoperative morbidity and mortality. Episodes of hypotension during surgery are associated with an increased risk of acute kidney injury, stroke, cardiac events and death. Treating or preventing hypotension during general anesthesia and major surgery was found to improve outcomes. At this time, it is unclear what is the best vasopressor to maintain blood pressure during surgery.
Hypotension during anesthesia and surgery is commonly treated with vasopressors such as phenylephrine (PE), a synthetic pure vasoconstrictor, or norepinephrine (NE), which has both inotropic and vasoconstrictor activity. NE increases cardiac output and increases cardio-vascular coupling due to alpha-agonist effects compared to PE, a purely vasoconstrictive agent.
The investigators hypothesize that norepinephrine will be superior to phenylephrine. The effect size is expected to be modest, therefore requiring a large sample size, and will vary between subgroups determined by patients' individual characteristics.
This pilot trial (VEGA-1) will allow to 1) test the feasibility of the study using a cross-over cluster randomized controlled trial and 2) estimate the effect size of the use of NE or PE on post-operative outcome in the overall population but also investigate the Heterogeneity in Treatment Effect (HTE) of the drugs among subgroups or clusters of patients for designing a larger trial.
Design: pragmatic, cluster-randomized, open-labeled, multiple-crossover trial across hospital from University of California, San Francisco (UCSF) and University of California, Los Angeles (UCLA). Centers will be assigned to use either PE or NE for the first-line intravenous infusion of vasopressor in the OR. Data will be collected in routine clinical care and automatically extracted from the electronic health record (EHR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 Years and older
- •Surgery under general anesthesia and requiring infusion of vasopressors to maintain the mean arterial pressure.
- •Surgery duration>2 hours
排除标准
- •Cardiac surgery
- •Patients on ECMO
- •Organ transplantation
- •Outpatient (come-and-go surgery)
- •Obstetric procedures
- •Patient already receiving NE or PE before induction of anesthesia
- •Patients transferred immediately (i.e. within 24 hours) after surgery to another hospital.
- •Patients with severe trauma
研究组 & 干预措施
Phenylephrine
Phenylephrine continuous infusion as the first line vasopressor
干预措施: Phenylephrine (Drug)
Norepinephrine
Norepinephrine continuous infusion as the first line vasopressor
干预措施: Norepinephrine (Drug)
结局指标
主要结局
Number of Participants With Assigned Vasopressor Given
时间窗: Anesthesia time, up to 24 hours
First line vasopressor administration will be measured as a percent of total eligible participants with assigned vasopressor given during anesthesia time, up to 24 hours
次要结局
- Hospital Length of Stay(In-hospital, up to 30 days)
- Number of Participants Who Died Within 30 Days After Surgery(30 days)
- Number of Participants With Acute Kidney Injury (AKI)(7 days)
- Number of Participants With Severe Acute Kidney Injury(7 days)
- Number of Participants With Myocardial Injury After Non-cardiac Surgery (MINS)(7 days)
- Adverse Cardio-renal Events(7 days)
- Rehospitalization Within 30 Days(30 days)