- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03540511
Postoperative Troponin in Renal Dysfunction After Cardiac Surgery
March 3, 2020 updated by: Youn Joung Cho, MD, Seoul National University Hospital
Prognostic Value of Postoperative Troponin in Patients With Renal Dysfunction Undergoing Cardiac Surgery
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 03080
- Seoul National University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality
Time Frame: through study completion, average 3 years
|
mortality after cardiac surgery
|
through study completion, average 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2018
Primary Completion (Actual)
November 1, 2019
Study Completion (Actual)
November 1, 2019
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
May 28, 2018
First Posted (Actual)
May 30, 2018
Study Record Updates
Last Update Posted (Actual)
March 4, 2020
Last Update Submitted That Met QC Criteria
March 3, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TnI_CKD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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