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

Study Overview

• Status: Withdrawn
• Conditions: Myocardial Infarction; Stroke; Postoperative Complications; Death; Renal Failure
• Intervention / Treatment: 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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan School of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
incidence of postoperative all cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence of postoperative all cause mortality		1 year
incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)		1 year
incidence of morbidity and mortality for predefined subgroups	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	1 year
episode, duration, and extent of intraoperative hypotension and hypertension		intraoperative
Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality		1 year

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Michigan
• Investigators: Study Director: Anshuman Sharma, MD, Washington University School of Medicine; Principal Investigator: Sachin Kheterpal, MD, University of Michigan; Study Chair: Kevin Tremper, MD PhD, University of Michigan; Study Director: Dan Helsten, MD, Washington University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: August 7, 2012
• First Submitted That Met QC Criteria: December 17, 2013
• First Posted (Estimate): December 24, 2013

Study Record Updates

• Last Update Posted (Actual): January 29, 2018
• Last Update Submitted That Met QC Criteria: January 25, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: anesthesia; blood pressure; postoperative; MAP; intraoperative; mean arterial pressure
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Postoperative Complications
• Other Study ID Numbers: 201102154