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

This study is currently recruiting participants.
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

August 7, 2012
December 17, 2013
June 2011
July 2015   (final data collection date for primary outcome measure)
incidence of postoperative all cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02019342 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)
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.

Observational
Observational Model: Cohort
Not Provided
Not Provided
Non-Probability Sample

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

  • Death
  • Postoperative Complications
  • Myocardial Infarction
  • Stroke
  • Renal Failure
  • 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.
  • Other: Pre-quality improvement initiative
    Patients in the pre-quality improvement initiative arm would receive current standard practice.
  • Post-quality improvement cohort
    Patient cohort after FACE quality improvement initiative is implemented
    Intervention: Other: FACE quality improvement initiative (see below)
  • Pre-quality improvement cohort
    Patient cohort prior to implementation of FACE quality improvement initiative
    Intervention: Other: Pre-quality improvement initiative

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140000
December 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Michael S Avidan, MBBCh 314-747-4155 avidanm@wustl.edu
Contact: Beth Burnside, BA 314-747-3752 burnsideb@anest.wustl.edu
United States
 
NCT02019342
201102154
No
Michael Avidan, Washington University School of Medicine
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
Washington University School of Medicine
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP