Evaluation of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Early and Evolving Acute Kidney Injury (EVOLVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00445809
Recruitment Status : Completed
First Posted : March 9, 2007
Last Update Posted : August 4, 2009
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Brief Summary:
Some patients who undergo cardiovascular surgery requiring cardiopulmonary bypass will develop a kidney injury following their surgery. The purpose of this study is to take a blood sample from patients before they have this type of surgery and then at nine time points after their surgery to test their plasma for a biomarker called NGAL and compare the NGAL levels to their creatinine levels. We hypothesize that NGAL is an earlier marker for kidney injury than creatinine.

Condition or disease
Kidney Failure, Acute

Detailed Description:

Approximately 350 adults scheduled to undergo cardiac surgery involving the use of cardiopulmonary bypass will be enrolled. Blood samples will be obtained from all patients in the study for future measurement of both plasma NGAL and plasma creatinine levels in the same sample at each of nine time points.

Blood samples for later assessment using the Triage NGAL Test will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage. Testing with the Triage NGAL Test will be conducted at Biosite by trained laboratory personnel. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the patient.

The medical team caring for each study patient should obtain clinical laboratory tests per their usual post-operative routine and manage the patient accordingly. Any serum creatinine measurements obtained by the site as part of this routine care both pre-operatively and through Day 10 post-operatively will be recorded as well as any additional post-operative renal insults, the development of oliguria, the need for a nephrology consultation, initiation of dialysis and mortality will also be recorded through Day 10.

Study Type : Observational
Actual Enrollment : 355 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: EValuation Of NGAL in Early and eVolving Acute kidnEy Injury
Study Start Date : February 2007
Actual Primary Completion Date : December 2008
Actual Study Completion Date : April 2009

High Risk population for developing AKI during/after CABG surgery.
Medium Risk population for developing AKI during/after CABG surgery.

Biospecimen Retention:   Samples Without DNA
Blood Samples (3 10ml, 7 5ml) at ten timepoints over 5 days.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing CABG Surgery that are thought to have a risk of developing AKI during/after surgery.

4.2.1 Inclusion Criteria

  1. Male or female scheduled for cardiovascular surgery (other than cardiac transplant) requiring cardiopulmonary bypass
  2. 18 years of age or older

i. The first approximately 150 to200 patients enrolled must have:

• A Prediction of Acute Renal Failure Score ≥ 5 (see Reference 18 and Appendix B)

ii. The subsequent patients enrolled must have one or more of the following risk factors for post-bypass renal injury:

  • Age > 70;
  • Pre-operative creatinine > 1.4 mg/dL;
  • NYHA Class 3 or 4 heart failure or left ventricular ejection fraction < 35%;
  • Insulin-dependent diabetes mellitus;
  • Undergoing cardiac valve surgery;
  • History of previous cardiac surgery.

Exclusion Criteria:

  • Age < 18 years
  • Inability to obtain Informed Consent from patient or representative
  • Prisoners or other institutionalized or vulnerable individuals
  • Participation in an interventional clinical study within the previous 30 days
  • History of previous renal transplantation
  • Stage 5 chronic kidney disease (estimated GRF<15 mL/min/1.73m2) (See Appendix C)
  • Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinines or oliguria pre-operatively)
  • Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management
  • Any known or suspected renal ischemic insult(such as cardiac arrest)or nephrotoxic insult(other than intravascular contrast procedure) during the 48 hours prior to surgery
  • Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)infection, hepatitis B virus (HBV) infection or other infectious hepatitis
  • Pre-operative hematocrit <25%, recent blood transfusions have been administered to maintain hematocrit >25% or any other contraindication to obtaining the study-specified blood samples
  • Undergoing cardiac transplantation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00445809

United States, Colorado
St. Anthony's Central Hospital
Denver, Colorado, United States
United States, District of Columbia
George Washington University
Washington, District of Columbia, United States
United States, Maine
Maine Medical Center
Portland, Maine, United States
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
United States, New York
St. Peters Healthcare
Albany, New York, United States
New York Methodist
Brooklyn, New York, United States
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States
United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
United States, Texas
University of Texas, Houston
Houston, Texas, United States
Canada, British Columbia
University of British Columbia
Vancouver, British Columbia, Canada
Sponsors and Collaborators
Principal Investigator: Emil Paganini, MD The Cleveland Clinic

Responsible Party: Kyle Fortner, CRA, Biosite, Incorporated a subsidiary of Inverness Medical Innovations Identifier: NCT00445809     History of Changes
Other Study ID Numbers: BSTE-0401
First Posted: March 9, 2007    Key Record Dates
Last Update Posted: August 4, 2009
Last Verified: August 2009

Keywords provided by Biosite:
Cardiac Surgery with bypass
Cardiovascular surgery with cardiopulmonary bypass

Additional relevant MeSH terms:
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases