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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02019342
Recruitment Status : Withdrawn (unable to implement the intervention)
First Posted : December 24, 2013
Last Update Posted : January 29, 2018
University of Michigan
Information provided by (Responsible Party):
Michael Avidan, 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.

Condition or disease Intervention/treatment
Death Postoperative Complications Myocardial Infarction Stroke Renal Failure Other: FACE quality improvement initiative (see below) Other: Pre-quality improvement initiative

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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 Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study
Study Start Date : June 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Group/Cohort Intervention/treatment
Post-quality improvement cohort
Patient cohort after FACE quality improvement initiative is implemented
Other: FACE quality improvement initiative (see below)
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.
Pre-quality improvement cohort
Patient cohort prior to implementation of FACE quality improvement initiative
Other: Pre-quality improvement initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.

Primary Outcome Measures :
  1. incidence of postoperative all cause mortality [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. incidence of postoperative all cause mortality [ Time Frame: 1 year ]
  2. incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) [ Time Frame: 1 year ]
  3. incidence of morbidity and mortality for predefined subgroups [ Time Frame: 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

  4. episode, duration, and extent of intraoperative hypotension and hypertension [ Time Frame: intraoperative ]
  5. Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02019342

United States, Michigan
University of Michigan School of Medicine
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
University of Michigan
Principal Investigator: Michael S Avidan, MBBCh Washington University School of Medicine
Principal Investigator: Sachin Kheterpal, MD University of Michigan
Study Chair: Alex S Evers, MD Washington University School of Medicine
Study Chair: Kevin Tremper, MD PhD University of Michigan
Study Director: Anshuman Sharma, MD Washington University School of Medicine
Study Director: Dan Helsten, MD Washington University School of Medicine


Responsible Party: Michael Avidan, Director, Institute of Quality Improvement, Research & Informatics, Washington University School of Medicine Identifier: NCT02019342     History of Changes
Other Study ID Numbers: 201102154
First Posted: December 24, 2013    Key Record Dates
Last Update Posted: January 29, 2018
Last Verified: April 2017

Keywords provided by Michael Avidan, Washington University School of Medicine:
blood pressure
mean arterial pressure

Additional relevant MeSH terms:
Myocardial Infarction
Renal Insufficiency
Postoperative Complications
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases