Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00774137

Enrollment

1550

Registered

2008-10-17

Start date

2007-04-30

Completion date

2014-02-28

Last updated

2020-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Acute, Renal Insufficiency

Keywords

Acute Kidney Injury, IL-18, NGAL, Cystatin C, Biomarkers, Dialysis

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Changes in serum creatinine levels (absolute and percentage)	Measured in the 1 week after surgery

Secondary

Measure	Time frame
Doubling of serum creatinine, use of dialysis, or death	Measured during hospitalization

Countries

Canada, United States

Outcome results