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

Stroke Clinical Trial

— MAP-ALIVE  

Official title:

Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02019342
• Other study ID #: 201102154
• Status: Withdrawn
• Phase: N/A
• First received: August 7, 2012
• Last updated: January 25, 2018
• Start date: June 2011
• Est. completion date: January 2014

Study information

• Verified date: April 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Death
• Infarction
• Myocardial Infarction
• Postoperative Complications
• Renal Failure
• Renal Insufficiency
• Stroke

Intervention

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 initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.

Locations

Country	Name	City	State
United States	University of Michigan School of Medicine	Ann Arbor	Michigan
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	University of Michigan

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of postoperative all cause mortality		30 days
Secondary	incidence of postoperative all cause mortality		1 year
Secondary	incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)		1 year
Secondary	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
Secondary	episode, duration, and extent of intraoperative hypotension and hypertension		intraoperative
Secondary	Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality		1 year