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

Withdrawn

Phase N/A Results N/A

Trial Description

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

Detailed Description

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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

Conditions

Interventions

  • FACE quality improvement initiative (see below) Other
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Post-quality improvement cohort
    Description: Patient cohort after FACE quality improvement initiative is implemented
  • Pre-quality improvement initiative Other
    Intervention Desc: Patients in the pre-quality improvement initiative arm would receive current standard practice.
    ARM 1: Kind: Experimental
    Label: Pre-quality improvement cohort
    Description: Patient cohort prior to implementation of FACE quality improvement initiative

Trial Design

  • Observation: Cohort
  • Sampling: Non-Probability Sample

Trial Population

All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan

Outcomes

Type Measure Time Frame Safety Issue
Primary incidence of postoperative all cause mortality 30 days No
Secondary incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) 1 year No
Secondary incidence of morbidity and mortality for predefined subgroups 1 year No
Secondary episode, duration, and extent of intraoperative hypotension and hypertension intraoperative No
Secondary Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality 1 year No

Sponsors