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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Washington University School of Medicine
Sponsor:
Collaborator:
University of Michigan
Information provided by (Responsible Party):
Michael Avidan, Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02019342
First received: August 7, 2012
Last updated: December 17, 2013
Last verified: December 2013
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • incidence of postoperative all cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of postoperative all cause mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • incidence of morbidity and mortality for predefined subgroups [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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 [ Time Frame: intraoperative ] [ Designated as safety issue: No ]
  • Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 140000
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02019342

Contacts
Contact: Michael S Avidan, MBBCh 314-747-4155 avidanm@wustl.edu
Contact: Beth Burnside, BA 314-747-3752 burnsideb@anest.wustl.edu

Locations
United States, Michigan
University of Michigan School of Medicine Not yet recruiting
Ann Arbor, Michigan, United States, 48109
Principal Investigator: Sachin Kheterpal, MD         
United States, Missouri
Washington University School of Medicine Recruiting
St Louis, Missouri, United States, 63110
Principal Investigator: Michael S Avidan, MBBCh         
Sub-Investigator: Elizabeth Whitlock, MD         
Sub-Investigator: Sungkook A Park, BS         
Sponsors and Collaborators
Washington University School of Medicine
University of Michigan
Investigators
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
  More Information

Publications:

Responsible Party: Michael Avidan, Director, Institute of Quality Improvement, Research & Informatics, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02019342     History of Changes
Other Study ID Numbers: 201102154
Study First Received: August 7, 2012
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Washington University School of Medicine:
blood pressure
mean arterial pressure
MAP
intraoperative
postoperative
anesthesia

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Postoperative Complications
Renal Insufficiency
Stroke
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Kidney Diseases
Urologic Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 22, 2014