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

Withdrawn

• Conditions: Postoperative Complications; Death; Myocardial Infarction; Stroke; Renal Failure
• Interventions: Other: Pre-quality improvement initiative; Other: FACE quality improvement initiative (see below)

• Registration Number: NCT02019342
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2012-08-07
• Study First Submitted QC: 2013-12-17
• Study First Posted: 2013-12-24
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2017-04
• Last Update Submitted: 2018-01-25
• Last Update Posted: 2018-01-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012

Read More

Exclusion Criteria

• Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
• Patients without a Social Security Number

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-quality improvement cohort	Pre-quality improvement initiative	Patient cohort prior to implementation of FACE quality improvement initiative
Post-quality improvement cohort	FACE quality improvement initiative (see below)	Patient cohort after FACE quality improvement initiative is implemented

Primary Outcome Measures

Name	Time	Method
incidence of postoperative all cause mortality	30 days

Secondary Outcome Measures

Name	Time	Method
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	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
episode, duration, and extent of intraoperative hypotension and hypertension	intraoperative
Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality	1 year

Trial Locations

Locations (2)

University of Michigan School of Medicine; 🇺🇸 Ann Arbor, Michigan, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States