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Performance Measurement in Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT03785132
Recruitment Status : Recruiting
First Posted : December 24, 2018
Last Update Posted : December 24, 2018
Sponsor:
Information provided by (Responsible Party):
Youn Joung Cho, MD, Seoul National University Hospital

Brief Summary:
This study aimed to evaluate the relationship between the perioperative blood pressure and postoperative mortality after cardiac surgery using performance measurement (PM) of mean arterial pressure (MAP).

Condition or disease Intervention/treatment
Blood Pressure Procedure: Cardiac surgery

Detailed Description:
The authors conducted a retrospective cohort study of adult patients who underwent cardiac surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP as the reference value, and MBPs before, during and after the bypass as measured values. Univariable and multivariable logistic regression analyses were performed using PM parameters to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox proportional hazard model. Predictability of PM was assessed using the area under the receiver-operating characteristic curve (AUROC).

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Study Type : Observational
Estimated Enrollment : 1300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Group/Cohort Intervention/treatment
cardiac surgery
Patients who underwent cardiac surgery with cardiopulmonary bypass
Procedure: Cardiac surgery
The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality




Primary Outcome Measures :
  1. Mortality [ Time Frame: through study completion, average 3 years ]
    mortality after cardiac surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital
Criteria

Inclusion Criteria:

  • Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016 at Seoul National University Hospital.

Exclusion Criteria:

  • Patients without information on preoperative blood pressure or mortality.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03785132


Contacts
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Contact: Youn Joung Cho, MD 82-2-2072-2467 mingming7@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Contact: Youn Joung Cho, MD    82-2-2072-3108    mingming7@gmail.com   
Contact: Susie Yoon, MD    82-2-2072-7361    susiey87@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Principal Investigator: Youn Joung Cho, MD Seoul National University Hospital

Publications of Results:
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Responsible Party: Youn Joung Cho, MD, Clinical assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03785132     History of Changes
Other Study ID Numbers: PM_cardiac surgery
First Posted: December 24, 2018    Key Record Dates
Last Update Posted: December 24, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Youn Joung Cho, MD, Seoul National University Hospital:
blood pressure
performance measurement
cardiac surgery
mortality