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

25. januar 2018 oppdatert av: Michael Avidan, Washington University School of Medicine

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

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.

Studieoversikt

Detaljert beskrivelse

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 A similar rate has been observed at Barnes-Jewish Hospital (BJH) according to the investigators published and unpublished data from the B-Unaware (NCT00281489) and BAG-RECALL (NCT00682825) clinical trials.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

Studietype

Observasjonsmessig

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • University of Michigan School of Medicine
    • Missouri
      • Saint Louis, Missouri, Forente stater, 63110
        • Washington University School of Medicine

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Pre-quality improvement cohort
Patient cohort prior to implementation of FACE quality improvement initiative
Patients in the pre-quality improvement initiative arm would receive current standard practice.

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
incidence of postoperative all cause mortality
Tidsramme: 30 days
30 days

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
incidence of postoperative all cause mortality
Tidsramme: 1 year
1 year
incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)
Tidsramme: 1 year
1 year
incidence of morbidity and mortality for predefined subgroups
Tidsramme: 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
1 year
episode, duration, and extent of intraoperative hypotension and hypertension
Tidsramme: intraoperative
intraoperative
Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality
Tidsramme: 1 year
1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Samarbeidspartnere

Etterforskere

  • Studieleder: Anshuman Sharma, MD, Washington University School of Medicine
  • Hovedetterforsker: Sachin Kheterpal, MD, University of Michigan
  • Studiestol: Kevin Tremper, MD PhD, University of Michigan
  • Studieleder: Dan Helsten, MD, Washington University School of Medicine

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. juni 2011

Primær fullføring (Faktiske)

1. januar 2014

Studiet fullført (Faktiske)

1. januar 2014

Datoer for studieregistrering

Først innsendt

7. august 2012

Først innsendt som oppfylte QC-kriteriene

17. desember 2013

Først lagt ut (Anslag)

24. desember 2013

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

29. januar 2018

Siste oppdatering sendt inn som oppfylte QC-kriteriene

25. januar 2018

Sist bekreftet

1. april 2017

Mer informasjon

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere