AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality
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Purpose
The purpose of the study is to evaluate if acute kidney injury based on AKIN criteria is an independent predictor of 30-day mortality after cardiac surgery.
| Condition |
|---|
|
Kidney Failure |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | AKIN (Acute Kidney Injury Network) Criteria for Acute Kidney Injury After Cardiac Surgery - Risk Factors, Clinical Outcomes and 30-Day Mortality - Prospective Cohort Study |
- To test the hypothesis that patients with acute kidney injury after cardiac surgery have higher 30-day mortality. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To identify risk factors associated with acute kidney injury after cardiac surgery. [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To compare clinical outcomes in patients with and without acute kidney injury after cardiac surgery [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 1936 |
| Study Start Date: | January 2003 |
| Study Completion Date: | September 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
AKI (-)
Patients without acute kidney injury after cardiac surgery
|
|
AKI (+)
Patients with acute kidney injury after cardiac surgery
|
Detailed Description:
One thousand, nine hundred and thirty-six patients will be enrolled in this series and divided into to groups: Group AKI (-) - patients without acute kidney injury after cardiac surgery. Group AKI (+) - patients with acute kidney injury after cardiac surgery. 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. Risk Factors, Clinical Outcomes and 30-day Mortality will be evaluate in this patients.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Group AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit
Inclusion Criteria:
- Patients underwent coronary artery bypass grafting or cardiac valve surgery
- Patients with at least two serum creatinine values within 48 hours.
Exclusion Criteria:
- Patients with end-stage kidney disease requiring renal replacement therapy.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Mauricio N Machado, São José do Rio Preto Medical School |
| ClinicalTrials.gov Identifier: | NCT00777465 History of Changes |
| Other Study ID Numbers: | CAAE-3436.0.000.140-08 |
| Study First Received: | October 21, 2008 |
| Last Updated: | October 21, 2008 |
| Health Authority: | Brazil: National Committee of Ethics in Research |
Keywords provided by Hospital de Base:
|
Kidney failure Risk factors Clinical outcomes Coronary artery bypass |
Cardiac valve surgery Coronary artery bypass grafting Morbidity Mortality |
Additional relevant MeSH terms:
|
Acute Kidney Injury Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013