Status:
COMPLETED
Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Kidney Failure, Acute
Renal Insufficiency
Eligibility:
All Genders
Brief Summary
People who undergo coronary artery bypass grafting (CABG) or heart valve surgery may experience acute kidney injury (AKI) after their surgery. Current medical tests cannot identify AKI until approxima...
Detailed Description
AKI, which is indicated by a sudden change in serum creatinine levels, is a serious complication that can occur after a patient undergoes CABG or heart valve surgery. People who experience AKI after h...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Adults: (must have at least one of the following)
- Emergent surgery
- Pre-existing kidney impairment (baseline serum creatinine greater than 2 mg/dL)
- Ejection fraction less than 35%
- At least 70 years old
- Diabetes mellitus
- Combined CABG and valve surgery
- Repeat CABG or valve surgery
- Exclusion Criteria for Adults:
- Pre-operative acute kidney injury
- Enrolled in a conflicting research study
- Prior kidney transplantation
- Baseline serum creatinine level greater than 4.5 mg/dL
- Nephrotoxic drugs administered pre-operatively
- Surgery for only left ventricular assist device
- Inclusion Criteria for Children:
- Undergoing open heart surgery
- Exclusion Criteria for Children:
- Pre-existing acute kidney failure (greater than 50% decline in creatinine clearance)
Exclusion
Key Trial Info
Start Date :
April 1 2007
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1550 Patients enrolled
Trial Details
Trial ID
NCT00774137
Start Date
April 1 2007
End Date
February 1 2014
Last Update
April 3 2020
Active Locations (8)
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1
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
2
Danbury Hospital
Danbury, Connecticut, United States, 06810
3
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
4
University of Chicago School of Medicine
Chicago, Illinois, United States, 60637