Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- 30-day all-cause postoperative mortality
研究概览
简要总结
Patients undergoing anesthesia for non-cardiac surgery will be randomized to either having their anesthesia team alerted or kept blinded to extended periods of less than normal blood pressure with the goal of studying if providing these alerts leads to improved outcome after surgery (lower risk of death or complication in the days and weeks following surgery).
详细描述
Background:
We recently identified a significant association of postoperative morbidity and 30-day mortality with the concept of "hypotensive exposures" during anaesthesia. Specifically, we found in approximately 160,000 patients from 3 institutions (Cleveland Clinic, Vanderbilt University and Saint Louis University) that roughly every third adult patient undergoing a non-cardiac procedure under anaesthesia experienced twice the 30-day all-cause mortality portended by extended cumulative periods of less than normal intraoperative blood pressure. This association was independent of co-morbidity (Charlson Co-morbidity index), causing the same relative increase in mortality in "healthy" as in "sick" patients. A new method was introduced to quantify hypotensive exposures in form of a novel risk score called the SLUScore™, a score with values from ranging from 0 (no hypotensive exposure) to a maximum of 31 (the maximal number of exposures exceeded of a certain risk-based set of limits for time accumulated at a mean arterial blood pressure below thresholds between 75 and 45 mm Hg), with each increment of the SLUScore™ portending an equivalent 5% increase in 30-day postoperative mortality.
Hypothesis:
We test the hypothesis that alerting the anaesthesia care team to progressive hypotensive exposures (a progressive increase in their SLUScore™) improves 30-day survival. This will be tested in a prospective, randomised trial.
Methods and Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any adult patient presenting for any type of non-cardiac procedure performed under any type of anesthesia
排除标准
- •Pediatric patients (< 18 yrs of age)
- •Obstetric patients
结局指标
主要结局
30-day all-cause postoperative mortality
时间窗: 30-days
This addresses the known rather high rate of death within 30 days following non-cardiac surgical or interventional procedures
次要结局
- Composite outcomes(one week)
研究者
Wolf H. Stapelfeldt, MD
Professor
St. Louis University
