Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

Renal Insufficiency Clinical Trial

Official title:

Phase IV Multi Center Validation Study of Novel Biomarkers of Acute Kidney Injury After Cardiac Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774137
• Other study ID #: 0603001221
• Secondary ID: R01HL085757
• Status: Completed
• Start date: April 2007
• Est. completion date: February 2014

Study information

• Verified date: April 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1550
• Est. completion date: February 2014
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Kidney Injury
• Kidney Failure, Acute
• Renal Insufficiency

Locations

Country	Name	City	State
Canada	London Health Sciences Centre	London	Ontario
Canada	Montreal Children's Hospital at McGill University Health Centre	Montreal	Quebec
United States	University of Chicago School of Medicine	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Danbury Hospital	Danbury	Connecticut
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Duke Clinical Research Institute	Durham	North Carolina
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Heart, Lung, and Blood Institute (NHLBI)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (5)

Li S, Krawczeski CD, Zappitelli M, Devarajan P, Thiessen-Philbrook H, Coca SG, Kim RW, Parikh CR; TRIBE-AKI Consortium. Incidence, risk factors, and outcomes of acute kidney injury after pediatric cardiac surgery: a prospective multicenter study. Crit Car — View Citation

Parikh CR, Coca SG, Thiessen-Philbrook H, Shlipak MG, Koyner JL, Wang Z, Edelstein CL, Devarajan P, Patel UD, Zappitelli M, Krawczeski CD, Passik CS, Swaminathan M, Garg AX; TRIBE-AKI Consortium. Postoperative biomarkers predict acute kidney injury and po — View Citation

Parikh CR, Devarajan P, Zappitelli M, Sint K, Thiessen-Philbrook H, Li S, Kim RW, Koyner JL, Coca SG, Edelstein CL, Shlipak MG, Garg AX, Krawczeski CD; TRIBE-AKI Consortium. Postoperative biomarkers predict acute kidney injury and poor outcomes after pedi — View Citation

Shlipak MG, Coca SG, Wang Z, Devarajan P, Koyner JL, Patel UD, Thiessen-Philbrook H, Garg AX, Parikh CR; TRIBE-AKI Consortium. Presurgical serum cystatin C and risk of acute kidney injury after cardiac surgery. Am J Kidney Dis. 2011 Sep;58(3):366-73. doi: — View Citation

Zappitelli M, Krawczeski CD, Devarajan P, Wang Z, Sint K, Thiessen-Philbrook H, Li S, Bennett MR, Ma Q, Shlipak MG, Garg AX, Parikh CR; TRIBE-AKI consortium. Early postoperative serum cystatin C predicts severe acute kidney injury following pediatric card — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum creatinine levels (absolute and percentage)		Measured in the 1 week after surgery
Secondary	Doubling of serum creatinine, use of dialysis, or death		Measured during hospitalization

External Links

•   Translational Research Investigating Biomarker Endpoints Consortium Website
•   Yale