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

This study has been completed.
Sponsor:
Information provided by:
Biosite
ClinicalTrials.gov Identifier:
NCT00445809
First received: February 15, 2007
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

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
Kidney Failure, Acute

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: EValuation Of NGAL in Early and eVolving Acute kidnEy Injury

Further study details as provided by Biosite:

Biospecimen Retention:   Samples Without DNA

Blood Samples (3 10ml, 7 5ml) at ten timepoints over 5 days.


Enrollment: 355
Study Start Date: February 2007
Study Completion Date: April 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
High Risk population for developing AKI during/after CABG surgery.
2
Medium Risk population for developing AKI during/after CABG surgery.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445809

Locations
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
Biosite
Investigators
Principal Investigator: Emil Paganini, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Kyle Fortner, CRA, Biosite, Incorporated a subsidiary of Inverness Medical Innovations
ClinicalTrials.gov Identifier: NCT00445809     History of Changes
Other Study ID Numbers: BSTE-0401
Study First Received: February 15, 2007
Last Updated: August 3, 2009
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on November 27, 2014