Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)
NCT ID: NCT02019342
Last Updated: 2018-01-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2011-06-30
2014-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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Post-quality improvement cohort
Patient cohort after FACE quality improvement initiative is implemented
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
Pre-quality improvement initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.
Interventions
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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 initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients without a Social Security Number
18 Years
ALL
No
Sponsors
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University of Michigan
OTHER
Washington University School of Medicine
OTHER
Responsible Party
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Michael Avidan
Director, Institute of Quality Improvement, Research & Informatics
Principal Investigators
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Michael S Avidan, MBBCh
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Sachin Kheterpal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Alex S Evers, MD
Role: STUDY_CHAIR
Washington University School of Medicine
Kevin Tremper, MD PhD
Role: STUDY_CHAIR
University of Michigan
Anshuman Sharma, MD
Role: STUDY_DIRECTOR
Washington University School of Medicine
Dan Helsten, MD
Role: STUDY_DIRECTOR
Washington University School of Medicine
Locations
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University of Michigan School of Medicine
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Countries
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References
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Noordzij PG, Poldermans D, Schouten O, Bax JJ, Schreiner FA, Boersma E. Postoperative mortality in The Netherlands: a population-based analysis of surgery-specific risk in adults. Anesthesiology. 2010 May;112(5):1105-15. doi: 10.1097/ALN.0b013e3181d5f95c.
Kertai MD, Pal N, Palanca BJ, Lin N, Searleman SA, Zhang L, Burnside BA, Finkel KJ, Avidan MS; B-Unaware Study Group. Association of perioperative risk factors and cumulative duration of low bispectral index with intermediate-term mortality after cardiac surgery in the B-Unaware Trial. Anesthesiology. 2010 May;112(5):1116-27. doi: 10.1097/ALN.0b013e3181d5e0a3.
Monk TG, Saini V, Weldon BC, Sigl JC. Anesthetic management and one-year mortality after noncardiac surgery. Anesth Analg. 2005 Jan;100(1):4-10. doi: 10.1213/01.ANE.0000147519.82841.5E.
Bijker JB, van Klei WA, Vergouwe Y, Eleveld DJ, van Wolfswinkel L, Moons KG, Kalkman CJ. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology. 2009 Dec;111(6):1217-26. doi: 10.1097/ALN.0b013e3181c14930.
Kheterpal S, Tremper KK, Heung M, Rosenberg AL, Englesbe M, Shanks AM, Campbell DA Jr. Development and validation of an acute kidney injury risk index for patients undergoing general surgery: results from a national data set. Anesthesiology. 2009 Mar;110(3):505-15. doi: 10.1097/ALN.0b013e3181979440.
Aronson S, Stafford-Smith M, Phillips-Bute B, Shaw A, Gaca J, Newman M; Cardiothoracic Anesthesiology Research Endeavors. Intraoperative systolic blood pressure variability predicts 30-day mortality in aortocoronary bypass surgery patients. Anesthesiology. 2010 Aug;113(2):305-12. doi: 10.1097/ALN.0b013e3181e07ee9.
Other Identifiers
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201102154
Identifier Type: -
Identifier Source: org_study_id
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