Clinical trial NCT02019342: Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)
Official title: Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Death
Postoperative Complications
Myocardial Infarction
Stroke
Renal Failure
Keywords: blood pressure
mean arterial pressure
MAP
intraoperative
postoperative
anesthesia
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Michigan
First posted: 2013-12-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan

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.

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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 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

Primary outcomes:
measure: incidence of postoperative all cause mortality
timeFrame: 30 days
Secondary outcomes:
measure: incidence of postoperative all cause mortality
timeFrame: 1 year
measure: incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)
timeFrame: 1 year
measure: incidence of morbidity and mortality for predefined subgroups
timeFrame: 1 year
measure: episode, duration, and extent of intraoperative hypotension and hypertension
timeFrame: intraoperative
measure: Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan School of Medicine
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael S Avidan, MBBCh
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Sachin Kheterpal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Alex S Evers, MD
role: STUDY_CHAIR
affiliation: University of Michigan
name: Kevin Tremper, MD PhD
role: STUDY_CHAIR
affiliation: Washington University School of Medicine
name: Anshuman Sharma, MD
role: STUDY_DIRECTOR
affiliation: Washington University School of Medicine
name: Dan Helsten, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.