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
- 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.
A tanulmány áttekintése
Állapot
Részletes leírás
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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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.
Tanulmány típusa
Kapcsolatok és helyek
Tanulmányi helyek
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-
Michigan
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Ann Arbor, Michigan, Egyesült Államok, 48109
- University of Michigan School of Medicine
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Missouri
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Saint Louis, Missouri, Egyesült Államok, 63110
- Washington University School of Medicine
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-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Mintavételi módszer
Tanulmányi populáció
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
Kohorszok és beavatkozások
Csoport / Kohorsz |
Beavatkozás / kezelés |
|---|---|
|
Post-quality improvement cohort
Patient cohort after FACE quality improvement initiative is implemented
|
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.
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Pre-quality improvement cohort
Patient cohort prior to implementation of FACE quality improvement initiative
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Patients in the pre-quality improvement initiative arm would receive current standard practice.
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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Időkeret |
|---|---|
|
incidence of postoperative all cause mortality
Időkeret: 30 days
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30 days
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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
incidence of postoperative all cause mortality
Időkeret: 1 year
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1 year
|
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incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)
Időkeret: 1 year
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1 year
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incidence of morbidity and mortality for predefined subgroups
Időkeret: 1 year
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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
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1 year
|
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episode, duration, and extent of intraoperative hypotension and hypertension
Időkeret: intraoperative
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intraoperative
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Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality
Időkeret: 1 year
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1 year
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Együttműködők és nyomozók
Együttműködők
Nyomozók
- Tanulmányi igazgató: Anshuman Sharma, MD, Washington University School of Medicine
- Kutatásvezető: Sachin Kheterpal, MD, University of Michigan
- Tanulmányi szék: Kevin Tremper, MD PhD, University of Michigan
- Tanulmányi igazgató: Dan Helsten, MD, Washington University School of Medicine
Publikációk és hasznos linkek
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Becslés)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- 201102154
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