- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02081261
Predicting Acute Kidney Injury After Coronary Artery Bypass Graft
June 14, 2016 updated by: WonHo Kim, Samsung Medical Center
Predicting Acute Kidney Injury After Coronary Artery Bypass Graft : a Simplified Clinical Risk Scoring Model
Acute kidney injury after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome.
There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully.
The investigators attempt to evaluate the influence of perioperative clinical variables including preoperative medication, preoperative albumin level, uric acid concentration, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic function) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Acute kidney injury (AKI) after cardiac surgery is a major complication after cardiac surgery and has been reported to be associated with adverse outcome.
There have been many studies reporting risk factor of acute kidney injury after cardiac surgery, but the influence of perioperative variables related to anesthesia and perioperative medication has not been evaluated fully.
The investigators attempt to evaluate the influence of preoperative medication, preoperative albumin level, uric acid concentration, NL ratio, anesthesia technique, use of hydroxyethyl starch, blood glucose level, intraoperative medication, perioperative cardiac function (systolic and diastolic) and hemodynamic variables during surgery on the incidence of acute kidney injury after coronary artery bypass graft.
Preoperative and postoperative diastolic dysfunction may be associated with postoperative AKI.
In addition, preoperative neutrophil-lymphocyte ratio (NLR) which has been reported to be a marked for systemic inflammation and was associated with prognosis in cardiac patients undergoing coronary artery bypass graft or percutaneous coronary intervention.
This preoperative or immediate postoperative NLR might be able to predict AKI after coronary artery bypass surgery.
Study Type
Observational
Enrollment (Actual)
877
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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-
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Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
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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
patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center
Description
Inclusion Criteria:
- patients who underwent coronary artery bypass surgery during between 2010 and 2012 in Samsung Medical Center
Exclusion Criteria:
- lack of postoperative creatinine or urine output data
- patients who expired within 24hours after surgery
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Coronary artery bypass surgery
patients who underwent coronary artery bypass surgery between 2010 and 2012 in Samsung Medical Center
|
coronary artery bypass surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute kidney injury diagnosis defined by KDIGO criteria
Time Frame: during 7 days after surgery
|
Acute kidney injury diagnosis defined by KDIGO criteria (Stage 1, 2, 3) during seven days after surgery
|
during 7 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria
Time Frame: within 48 hours after surgery
|
Acute kidney injury as defined by AKIN (acute kidney injury network) criteria
|
within 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
January 1, 2014
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
March 5, 2014
First Submitted That Met QC Criteria
March 6, 2014
First Posted (Estimate)
March 7, 2014
Study Record Updates
Last Update Posted (Estimate)
June 16, 2016
Last Update Submitted That Met QC Criteria
June 14, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2013-12-116
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.