- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00777465
Acute Kidney Injury After Cardiac Surgery Based on KDIGO Criteria
May 19, 2014 updated by: Mauricio de Nassau Machado, Hospital de Base
Prognostic Value of Acute Kidney Injury After Cardiac Surgery According to Kidney Disease: Improving Global Outcomes Definition and Staging (KDIGO) Criteria
The aim of this study was to apply the acute kidney injury criteria based on KDIGO classification in a population of patients undergoing cardiac surgery [coronary artery bypass grafting (CABG) or cardiac valve surgery (CVS)] and evaluate its impact as a predictor of 30-day mortality.
Study Overview
Status
Completed
Conditions
Detailed Description
This was a single center study.
We evaluated retrospectively patients from the Cardiac Surgery Intensive Care Unit in Hospital de Base, São José do Rio Preto Medical School, São Paulo, Brazil.
Demographics, type of surgery, laboratory data and preoperative, perioperative, and postoperative information were retrieved from a prospectively collected database of 2878 patients older than 18 years undergoing isolated CABG (1786) or CVS (1092), from January 2003 to June 2013.
After applying the exclusion criteria (51 patients with incomplete data and 23 patients with end-stage kidney disease) we analyzed 2804 patients in total, 1738 (62%) underwent CABG and 1066 (38%) underwent CVS.
Study Type
Observational
Enrollment (Actual)
2804
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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São Paulo
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São José do Rio Preto, São Paulo, Brazil, 15090-000
- Hospital de Base
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients selected consecutively after cardiac surgery (CABG or CVS) in a setting of postoperative intensive care unit.
Description
Inclusion Criteria:
patients undergoing isolated coronary artery bypass grafting or cardiac valve surgery.
Exclusion Criteria:
patients with incomplete data and patients with end-stage kidney disease.
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 |
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KDIGO 0
Patients with no acute kidney injury after cardiac surgery
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KDIGO 1
Patients with acute kidney injury KDIGO stage 1 after cardiac surgery (Increase in SCr by ≥ 0.3 mg/dL (≥ 26.5 lmol/L) or 1.5 to 1.9 times baseline)
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KDIGO 2
Patients with acute kidney injury KDIGO stage 2 after cardiac surgery (2.0 to 2.9 times baseline SCr)
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KDIGO 3
Patients with acute kidney injury KDIGO stage 3 after cardiac surgery (3.0 times baseline or more; or increase in SCr to ≥ 4.0 mg/dL; or initiation of renal replacement therapy)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute Kidney Injury after cardiac surgery as a independent predictor of 30-day mortality
Time Frame: 30 days
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To test the hypothesis that the acute kidney injury based on KDIGO criteria after cardiac surgery is a independent predictor of 30-day mortality
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30 days
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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, 2003
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
October 21, 2008
First Submitted That Met QC Criteria
October 21, 2008
First Posted (Estimate)
October 22, 2008
Study Record Updates
Last Update Posted (Estimate)
May 21, 2014
Last Update Submitted That Met QC Criteria
May 19, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE-3436.0.000.140-08
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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