- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00780845
AKIN Criteria: Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft (CABG)
November 3, 2008 updated by: Hospital de Base
AKIN (Acute Kidney Injury Network): Acute Kidney Injury After On-Pump Coronary Artery Bypass Graft Surgery
The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.
Study Overview
Status
Completed
Conditions
Detailed Description
Eight hundred and seventeen patients was enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after on-pump CABG.
Group AKI (+) - patients with acute kidney injury after on-pump CABG.
AKI was defined as an absolute increase in serum creatinine (SCr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in SCr of more than or equal to 50% (1.5-fold from baseline).
The change in SCr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in ICU.
Clinical Outcomes and 30-day mortality was evaluate in this patients.
Study Type
Observational
Enrollment (Actual)
817
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
Groups AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit
Description
Inclusion Criteria:
- Patients underwent on-pump coronary artery bypass grafting
- Patients with at least two serum creatinine values within 48 hours.
Exclusion Criteria:
- Patients with end-stage kidney disease requiring renal replacement therapy.
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 |
---|
AKI (-)
Patients without acute kidney injury after on-pump CABG
|
AKI (+)
Patients with acute kidney injury after on-pump CABG
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality
Time Frame: 30 days
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG
Time Frame: 30 days
|
30 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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
January 1, 2003
Primary Completion (ACTUAL)
January 1, 2008
Study Completion (ACTUAL)
January 1, 2008
Study Registration Dates
First Submitted
October 27, 2008
First Submitted That Met QC Criteria
October 27, 2008
First Posted (ESTIMATE)
October 28, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
November 4, 2008
Last Update Submitted That Met QC Criteria
November 3, 2008
Last Verified
October 1, 2008
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE-3438.0.000.140-08
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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