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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00780845
Other study ID # CAAE-3438.0.000.140-08
Secondary ID
Status Completed
Phase N/A
First received October 27, 2008
Last updated November 3, 2008
Start date January 2003
Est. completion date January 2008

Study information

Verified date October 2008
Source Hospital de Base
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical Trial Summary

The purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump CABG.


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.


Recruitment information / eligibility

Status Completed
Enrollment 817
Est. completion date January 2008
Est. primary completion date January 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Hospital de Base

Outcome

Type Measure Description Time frame Safety issue
Primary To test the hypothesis that patients with acute kidney injury after on-pump CABG have higher 30-day mortality 30 days No
Secondary To compare clinical outcomes in patients with and without acute kidney injury after on-pump CABG 30 days No
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