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临床试验/NCT02217969
NCT02217969撤回不适用

Prospective, Randomized Trial of Alerting to Extended Hypotensive Exposures on Long-Term Outcome Following Adult Non-Cardiac Surgical Procedures: The SLUScore™ Trial

St. Louis University2 个研究点 分布在 1 个国家开始时间: 2018年7月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolf H. Stapelfeldt, MD

Professor

St. Louis University

研究点 (2)

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