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Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00774137
Recruitment Status : Completed
First Posted : October 17, 2008
Last Update Posted : April 3, 2020
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Yale University

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 approximately 48 hours after it occurs. This study will examine three new biomarkers in blood and urine that may provide a more effective and faster way of predicting AKI in people who undergo CABG or heart valve surgery.

Condition or disease
Kidney Failure, Acute Renal Insufficiency

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 heart surgery may be at increased risk for post-operative complications, including long-term kidney failure or heart damage. AKI is currently identified by testing serum creatinine levels in the blood, which is the traditional marker of kidney function. However, serum creatinine levels can be affected by other non-kidney-related factors and may not positively identify AKI until 48 hours after it begins. This study will examine three new biomarkers found in urine and blood-urine interleukin 18 (IL-18), neutrophil gelatinase-associated lipocalin (NGAL), and cystatin C-that may be able to predict AKI more effectively and faster than serum creatinine levels. In addition, study researchers will also determine if changes in these biomarkers can predict the severity of AKI more successfully than serum creatinine tests.

This study will enroll people undergoing CABG or heart valve surgery at Yale-New Haven Hospital. Before the surgery and once a day for 5 days after the surgery, blood and urine collection will occur. Study researchers will also review participants' medical records. Twelve months after hospital discharge, participants will return to the clinic for a follow-up visit for repeat blood and urine collection and to complete questionnaires. A portion of blood will be saved for future genetic testing; this is optional.

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Study Type : Observational
Actual Enrollment : 1550 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Phase IV Multi Center Validation Study of Novel Biomarkers of Acute Kidney Injury After Cardiac Surgery
Study Start Date : April 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Changes in serum creatinine levels (absolute and percentage) [ Time Frame: Measured in the 1 week after surgery ]

Secondary Outcome Measures :
  1. Doubling of serum creatinine, use of dialysis, or death [ Time Frame: Measured during hospitalization ]

Biospecimen Retention:   Samples With DNA
Urine, plasma, buffy coat (optional)

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  1. Adults undergoing CABG surgery or heart valve surgery.
  2. Children undergoing cardic surgery (requiring CABG) to correct congenital heart defects.

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774137

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United States, Colorado
University of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
United States, Connecticut
Danbury Hospital
Danbury, Connecticut, United States, 06810
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Illinois
University of Chicago School of Medicine
Chicago, Illinois, United States, 60637
United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Canada, Ontario
London Health Sciences Centre
London, Ontario, Canada, N6A 4G5
Canada, Quebec
Montreal Children's Hospital at McGill University Health Centre
Montreal, Quebec, Canada, H3H 1P3
Sponsors and Collaborators
Yale University
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Chirag R. Parikh, MD, PhD Yale University
Additional Information:
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT00774137    
Other Study ID Numbers: 0603001221
R01HL085757 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Yale University:
Acute Kidney Injury
Cystatin C
Additional relevant MeSH terms:
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Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases