NCT02019342

Brief Summary

The purpose of this study is to determine

  1. 1.whether intraoperative hypotension or hypertension is independently associated with postoperative mortality and morbidity
  2. 2.whether quality improvement interventions implemented at the University of Michigan and at Washington University:
  3. 3.decrease the extent and duration of intraoperative hypotension and hypertension.
  4. 4.are associated with decreased postoperative mortality and morbidity.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2011

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

December 24, 2013

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 29, 2018

Status Verified

April 1, 2017

Enrollment Period

2.6 years

First QC Date

August 7, 2012

Last Update Submit

January 25, 2018

Conditions

DeathPostoperative ComplicationsMyocardial InfarctionStrokeRenal Failure

Keywords

blood pressuremean arterial pressureMAPintraoperativepostoperativeanesthesia

Outcome Measures

Primary Outcomes (1)

  • incidence of postoperative all cause mortality

    30 days

Secondary Outcomes (5)

  • incidence of postoperative all cause mortality

    1 year

  • incidence of major postoperative morbidity (e.g. myocardial infarction, stroke, renal failure)

    1 year

  • incidence of morbidity and mortality for predefined subgroups

    1 year

  • episode, duration, and extent of intraoperative hypotension and hypertension

    intraoperative

  • Dose-dependent relationship between intraoperative hypotension/hypertension and postoperative morbidity and mortality

    1 year

Study Arms (2)

Post-quality improvement cohort

Patient cohort after FACE quality improvement initiative is implemented

Other: FACE quality improvement initiative (see below)

Pre-quality improvement cohort

Patient cohort prior to implementation of FACE quality improvement initiative

Other: Pre-quality improvement initiative

Interventions

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.

Post-quality improvement cohort
Pre-quality improvement initiativeOTHER

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

Pre-quality improvement cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • All patients undergoing surgery at Barnes-Jewish Hospital or the University of Michigan between 8/1/2009 and 10/31/2012

You may not qualify if:

  • Patients undergoing organ harvest or terminal surgical procedure (American Society of Anesthesiologists physical status 6)
  • Patients without a Social Security Number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Michigan School of Medicine

Ann Arbor, Michigan, 48109, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (6)

  • 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.

    PMID: 20418691BACKGROUND

  • 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.

    PMID: 20418692BACKGROUND

  • 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.

    PMID: 15616043BACKGROUND

  • 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.

    PMID: 19934864BACKGROUND

  • 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.

    PMID: 19212261BACKGROUND

  • 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.

    PMID: 20571360BACKGROUND

MeSH Terms

Conditions

DeathPostoperative ComplicationsMyocardial InfarctionStrokeRenal Insufficiency

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaNecrosisCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Michael S Avidan, MBBCh

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

  • Sachin Kheterpal, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

  • Alex S Evers, MD

    Washington University School of Medicine

    STUDY CHAIR

  • Kevin Tremper, MD PhD

    University of Michigan

    STUDY CHAIR

  • Anshuman Sharma, MD

    Washington University School of Medicine

    STUDY DIRECTOR

  • Dan Helsten, MD

    Washington University School of Medicine

    STUDY DIRECTOR
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Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Institute of Quality Improvement, Research & Informatics

Study Record Dates

First Submitted

August 7, 2012

First Posted

December 24, 2013

Study Start

June 1, 2011

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 29, 2018

Record last verified: 2017-04

Locations

US(2)