Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

Sponsor

Yale University (Other)

Overall Status

Completed

CT.gov ID

NCT00774137

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

1,550

Enrollment

Locations

82.1

Duration (Months)

193.8

Patients Per Site

2.4

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Apr 1, 2007

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2014

Outcome Measures

Primary Outcome Measures

Changes in serum creatinine levels (absolute and percentage) [Measured in the 1 week after surgery]

Secondary Outcome Measures

Doubling of serum creatinine, use of dialysis, or death [Measured during hospitalization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Duke Clinical Research Institute	Durham	North Carolina	United States	27705
6	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio	United States	45229
7	London Health Sciences Centre	London	Ontario	Canada	N6A 4G5
8	Montreal Children's Hospital at McGill University Health Centre	Montreal	Quebec	Canada	H3H 1P3