DeathMAP-ALIVENCT02019342
Study to Determine the Impact of Intraoperative Blood Pressure Management on Postoperative Outcomes (MAP-ALIVE)
An observational study of Death and Postoperative Complications, run by Washington University School of Medicine at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Postoperative Complications, Myocardial Infarction
- What is being tested?
- FACE quality improvement initiative (see below) and Pre-quality improvement initiative
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Jan 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan
Who may be able to join
- All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012
Who cannot join
- Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
- Patients without a Social Security Number
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan School of Medicine
Ann Arbor, Michigan, 48109
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study
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.
Read the 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.
- Conditions
- Death, Postoperative Complications, Myocardial Infarction, Stroke, Renal Failure
- Being tested
- FACE quality improvement initiative (see below), Pre-quality improvement initiative
- Keywords
- blood pressure, mean arterial pressure, MAP, intraoperative, postoperative, anesthesia
- Medical subject headings
- Death, Postoperative Complications, Myocardial Infarction, Stroke, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACE quality improvement initiative (see below)Other
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 initiativeOther
Patients in the pre-quality improvement initiative arm would receive current standard practice.
| Study group | Role | What they receive |
|---|---|---|
| Post-quality improvement cohort | Patient cohort after FACE quality improvement initiative is implemented Receives: Other: FACE quality improvement initiative (see below) | |
| Pre-quality improvement cohort | Patient cohort prior to implementation of FACE quality improvement initiative Receives: Other: Pre-quality improvement initiative |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postoperative all cause mortality
Measured: 30 days
Secondary outcomes (5)
incidence of postoperative all cause mortality
Measured: 1 year
incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)
Measured: 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
Measured: 1 year
episode, duration, and extent of intraoperative hypotension and hypertension
Measured: intraoperative
Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startJun 2011
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: unable to implement the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan
- Responsible party
- Principal investigator, Michael Avidan, Washington University School of Medicine
- Investigators
- Michael S Avidan, MBBCh, Principal investigator, Washington University School of MedicineSachin Kheterpal, MD, Principal investigator, University of MichiganAlex S Evers, MD, Study chair, Washington University School of MedicineKevin Tremper, MD PhD, Study chair, University of MichiganAnshuman Sharma, MD, Study director, Washington University School of MedicineDan Helsten, MD, Study director, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019342
- Sponsor's protocol ID
- 201102154
- Acronym
- MAP-ALIVE
- Status last verified
- Apr 2017
- First submitted
- 7 Aug 2012
- Last updated
- 29 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20418691Kertai 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.
PubMed 20418692Monk 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.
PubMed 15616043Bijker 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.
PubMed 19934864Kheterpal 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.
PubMed 19212261Aronson 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.
PubMed 20571360
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mean Arterial Pressure Alert Level Impact on Vital Endpoint: the MAP-ALIVE Study
- ClinicalTrials.gov ID
- NCT02019342
- Acronym / sponsor ID
- MAP-ALIVE / 201102154
- Conditions
- Death, Postoperative Complications, Myocardial Infarction, Stroke, Renal Failure
- Keywords
- blood pressure, mean arterial pressure, MAP, intraoperative, postoperative, anesthesia
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: unable to implement the intervention
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Michigan
- Study start
- Jun 2011
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-quality improvement cohort | – | Other: FACE quality improvement initiative (see below)Patient cohort after FACE quality improvement initiative is implemented |
| Pre-quality improvement cohort | – | Other: Pre-quality improvement initiativePatient cohort prior to implementation of FACE quality improvement initiative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan
Key inclusion criteria (1 listed)
- All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012
Key exclusion criteria (2 listed)
- Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
- Patients without a Social Security Number
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | Post-quality improvement cohort |
| Pre-quality improvement initiativePatients in the pre-quality improvement initiative arm would receive current standard practice. | Other | Pre-quality improvement cohort |
Primary outcome
incidence of postoperative all cause mortality
Time frame: 30 days
5 secondary outcomes
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2018.
- Background: PubMed 20418691Noordzij 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.
- Background: PubMed 20418692Kertai 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.
- Background: PubMed 15616043Monk 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.
- Background: PubMed 19934864Bijker 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.
- Background: PubMed 19212261Kheterpal 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.
- Background: PubMed 20571360Aronson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael S Avidan, MBBCh principal investigator
Washington University School of Medicine
Sachin Kheterpal, MD principal investigator
University of Michigan
Alex S Evers, MD study chair
Washington University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Postoperative Complications, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postoperative all cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02019342, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2018.