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



Status:Withdrawn
Conditions:Renal Impairment / Chronic Kidney Disease, Cardiology, Hospital, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Nephrology / Urology, Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:1/31/2018
Start Date:June 2011
End Date:January 2014

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

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.

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Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data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.

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
We found this trial at
2
sites
1150 West Medical Center Drive
Ann Arbor, Michigan 48109
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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