Examining New Diagnostic Tests for Acute Kidney Injury After Heart Surgery

April 1, 2020 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

1550

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • London Health Sciences Centre
    • Quebec
      • Montreal, Quebec, Canada, H3H 1P3
        • Montreal Children's Hospital at McGill University Health Centre
  • United States
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Health Sciences Center
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Danbury Hospital
      • New Haven, Connecticut, United States, 06510
        • Yale University School of Medicine
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago School of Medicine
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Clinical Research Institute
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Doubling of serum creatinine, use of dialysis, or death
Time Frame: Measured during hospitalization
Measured during hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Chirag R. Parikh, MD, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 16, 2008

First Submitted That Met QC Criteria

October 16, 2008

First Posted (Estimate)

October 17, 2008

Study Record Updates

Last Update Posted (Actual)

April 3, 2020

Last Update Submitted That Met QC Criteria

April 1, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0603001221
  • R01HL085757 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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