Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- incidence of postoperative all cause mortality
研究概览
简要总结
The purpose of this study is to determine
-
whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity
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whether quality improvement interventions implemented at the University of Michigan and at Washington University:
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decrease the extent and duration of intraoperative hypotension and hypertension.
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are associated with decreased postoperative mortality and morbidity.
详细描述
Recent epidemiological data from an European study suggests that the 30-day postoperative mortality rate reaches a rate of about 1 in 50. A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials. Many factors are associated strongly and independently with postoperative morbidity and mortality; including patient age, functional status, comorbid medical conditions, and duration and invasiveness of the surgery. It is imperative to identify modifiable factors for possible intervention.
With the advent of electronic intraoperative medical record, intraoperative hemodynamic factors can be assessed as a potential contributor to postoperative morbidity and mortality. Recent studies have shown that intraoperative hypotension occurs commonly and is associated with both early and late postoperative mortality. The investigators goal is to conduct a study that might help to clarify whether intraoperative blood pressure management might be interdependently associated with postoperative morbidity and mortality. There are two phases in this trial: pre-quality improvement phase and post quality improvement phase. Pre-quality improvement phase data will be used as a baseline control group. Data from this phase will also be used to establish whether there appears to be an independent association between intraoperative blood pressure management and postoperative morbidity and mortality. The Anesthesiology Departments at Washington University in St. Louis and at the University of Michigan are implementing quality improvement initiatives in relation to intraoperative blood pressure management. Following implementation of the quality improvement initiatives, the investigators plan to determine whether: a) there is an improvement in intraoperative blood pressure management; b) whether there is a decrease in postoperative morbidity and mortality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012
排除标准
- •Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
- •Patients without a Social Security Number
结局指标
主要结局
incidence of postoperative all cause mortality
时间窗: 30 days
次要结局
- incidence of postoperative all cause mortality(1 year)
- incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)(1 year)
- incidence of morbidity and mortality for predefined subgroups(1 year)
- episode, duration, and extent of intraoperative hypotension and hypertension(intraoperative)
- Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality(1 year)
研究者
Michael Avidan
Director, Institute of Quality Improvement, Research & Informatics
Washington University School of Medicine