Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity whether quality improvement interventions implemented at the University of Michigan and at Washington University: decrease the extent and duration of intraoperative hypotension and hypertension. are associated with decreased postoperative mortality and morbidity.

Detailed Description
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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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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.

Official Title
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Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study

Conditions
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Death, Postoperative Complications, Myocardial Infarction, Stroke, Renal Failure

Intervention / Treatment
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* Other: FACE quality improvement initiative (see below)
* Other: Pre-quality improvement initiative


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012 Exclusion Criteria: Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6) Patients without a Social Security Number

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-quality improvement cohort<br>Patient cohort after FACE quality improvement initiative is implemented | Other: FACE quality improvement initiative (see below)<br>* Feedback (F): Regular feedback to practitioners; MAP Alerts (A): Change in electronic alert systems for high and low mean arterial pressure with patient specific alerts; Checklist (C): Interactive checklist in relation to the quality improvement initiative; Education campaign (E): Education campaigns about best intraoperative management of blood pressure.<br>|
| Pre-quality improvement cohort<br>Patient cohort prior to implementation of FACE quality improvement initiative | Other: Pre-quality improvement initiative<br>* Patients in the pre-quality improvement initiative arm would receive current standard practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative all cause mortality |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | patients with pre-existing hypertension, specific organ system diseases (coronary artery disease, cerebrovascular disease, peripheral vascular disease, renal dysfunction), elderly (>65 yrs of age), American Society of Anesthesiologist physical status 3,4,5, and patients receiving emergency surgery | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MAP, blood pressure, mean arterial pressure, intraoperative, postoperative, anesthesia