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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03785132
Other study ID # PM_cardiac surgery
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 1, 2018
Est. completion date November 1, 2019

Study information

Verified date March 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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).


Recruitment information / eligibility

Status Completed
Enrollment 1300
Est. completion date November 1, 2019
Est. primary completion date November 1, 2019
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Cardiac surgery
The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mortality mortality after cardiac surgery through study completion, average 3 years
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