AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality
| Tracking Information | |||||
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| First Received Date ICMJE | October 21, 2008 | ||||
| Last Updated Date | October 21, 2008 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | |||||
| Original Other Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | AKIN Criteria After Cardiac Surgery - Clinical Outcomes and 30-Day Mortality | ||||
| Official Title ICMJE | AKIN (Acute Kidney Injury Network) Criteria for Acute Kidney Injury After Cardiac Surgery - Risk Factors, Clinical Outcomes and 30-Day Mortality - Prospective Cohort Study | ||||
| Brief Summary | 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Biospecimen | |||||
| Sampling Method | Probability Sample | ||||
| Study Population | Group AKI (-) and AKI (+) selected consecutively after admission in cardiac surgery postoperative care unit |
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| Condition ICMJE | Kidney Failure | ||||
| Intervention ICMJE | |||||
| Study Group/Cohort (s) |
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| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1936 | ||||
| Completion Date | September 2008 | ||||
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Brazil | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00777465 | ||||
| Other Study ID Numbers ICMJE | CAAE-3436.0.000.140-08 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Mauricio N Machado, São José do Rio Preto Medical School | ||||
| Study Sponsor ICMJE | Hospital de Base | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Hospital de Base | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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