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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03540511
Other study ID # TnI_CKD
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 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

Elevated level of troponin is frequently observed among patients with renal dysfunction. Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. However, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.


Description:

This is a retrospective observational study to evaluate the prognostic value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery. Electrical medical records of patients who underwent cardiac surgery between 2004 and 2015 will be assessed. Perioperative laboratory data including troponin and glomerular filtration rate, type of surgery, and outcome variables including mortality will be analysed to determine the prognostic value of postoperative value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery.


Recruitment information / eligibility

Status Completed
Enrollment 5000
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 with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

Exclusion Criteria:

- Patients without laboratory information on glomerular filtration rate or troponin levels

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
postoperative troponin
assess postoperative troponin levels after cardiac surgery in patients with renal dysfunction

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, 

Outcome

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