Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE) (MAP-ALIVE)
|ClinicalTrials.gov Identifier: NCT02019342|
Recruitment Status : Withdrawn (unable to implement the intervention)
First Posted : December 24, 2013
Last Update Posted : January 29, 2018
The purpose of this study is to determine
- whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity
whether quality improvement interventions implemented at the University of Michigan and at Washington University:
- decrease the extent and duration of intraoperative hypotension and hypertension.
- are associated with decreased postoperative mortality and morbidity.
|Condition or disease||Intervention/treatment|
|Death Postoperative Complications Myocardial Infarction Stroke Renal Failure||Other: FACE quality improvement initiative (see below) Other: Pre-quality improvement initiative|
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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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|
|Actual Enrollment :||0 participants|
|Official Title:||Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study|
|Study Start Date :||June 2011|
|Actual Primary Completion Date :||January 2014|
|Actual Study Completion Date :||January 2014|
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.
- incidence of postoperative all cause mortality [ Time Frame: 30 days ]
- incidence of postoperative all cause mortality [ Time Frame: 1 year ]
- incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure) [ Time Frame: 1 year ]
- incidence of morbidity and mortality for predefined subgroups [ Time Frame: 1 year ]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 ]
- Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality [ Time Frame: 1 year ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02019342
|United States, Michigan|
|University of Michigan School of Medicine|
|Ann Arbor, Michigan, United States, 48109|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|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|