Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

Completed

• Conditions: Renal Insufficiency; Kidney Failure, Acute

• Registration Number: NCT00774137
• Lead Sponsor: 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.

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2008-10-16
• Study First Submitted QC: 2008-10-16
• Study First Posted: 2008-10-17
• Primary Completion: 2013-02
• Study Completion: 2014-02
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-01
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1550

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Doubling of serum creatinine, use of dialysis, or death	Measured during hospitalization

Trial Locations

Locations (8)

University of Colorado Health Sciences Center; 🇺🇸 Denver, Colorado, United States

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

Danbury Hospital; 🇺🇸 Danbury, Connecticut, United States

University of Chicago School of Medicine; 🇺🇸 Chicago, Illinois, United States

Duke Clinical Research Institute; 🇺🇸 Durham, North Carolina, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Montreal Children's Hospital at McGill University Health Centre; 🇨🇦 Montreal, Quebec, Canada