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Sponsored by: |
Biosite |
Information provided by: | Biosite |
ClinicalTrials.gov Identifier: | NCT00445809 |
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 |
MedlinePlus related topics: | Kidney Failure |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | EValuation Of NGAL in Early and eVolving Acute kidnEy Injury |
Blood Samples (3 10ml, 7 5ml) at ten timepoints over 5 days.
Estimated Enrollment: | 350 |
Study Start Date: | February 2007 |
Groups/Cohorts |
1
High Risk population for developing AKI during/after CABG surgery.
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2
Medium Risk population for developing AKI during/after CABG surgery.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients undergoing CABG Surgery that are thought to have a risk of developing AKI during/after surgery.
4.2.1 Inclusion Criteria
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:
Exclusion Criteria:
Contact: Suzanne Williamson | 858-805-2733 | swilliamson@biosite.com |
Contact: Kyle Fortner | 858-805-3032 | kfortner@biosite.com |
United States, Colorado | |||||
St. Anthony's Central Hospital | Recruiting | ||||
Denver, Colorado, United States | |||||
United States, District of Columbia | |||||
George Washington University | Recruiting | ||||
Washington, District of Columbia, United States | |||||
United States, Illinois | |||||
University of Chicago | Recruiting | ||||
Chicago, Illinois, United States | |||||
United States, Maine | |||||
Maine Medical Center | Recruiting | ||||
Portland, Maine, United States | |||||
United States, Massachusetts | |||||
Beth Israel Deaconess Medical Center | Recruiting | ||||
Boston, Massachusetts, United States | |||||
Massachusetts General Hospital | Recruiting | ||||
Boston, Massachusetts, United States | |||||
Contact: . . | |||||
Principal Investigator: Edwin Avery, MD | |||||
Massachusetts General Hospital | Recruiting | ||||
Boston, Massachusetts, United States | |||||
United States, Missouri | |||||
Washington University | Withdrawn | ||||
St. Louis, Missouri, United States | |||||
United States, New York | |||||
New York Methodist | Recruiting | ||||
Brooklyn, New York, United States | |||||
St. Peters Healthcare | Recruiting | ||||
Albany, New York, United States | |||||
United States, Ohio | |||||
Cleveland Clinic Foundation | Recruiting | ||||
Cleveland, Ohio, United States | |||||
United States, Pennsylvania | |||||
University of Pittsburgh | Recruiting | ||||
Pittsburgh, Pennsylvania, United States | |||||
United States, Texas | |||||
University of Texas, Houston | Recruiting | ||||
Houston, Texas, United States | |||||
Canada, British Columbia | |||||
University of British Columbia | Recruiting | ||||
Vancouver, British Columbia, Canada |
Biosite |
Principal Investigator: | Emil Paganini, MD | The Cleveland Clinic |
Responsible Party: | Biosite, Incorporated a subsidiary of Inverness Medical Innovations ( Rick SanGeorge ) |
Study ID Numbers: | BSTE-0401 |
First Received: | February 15, 2007 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00445809 |
Health Authority: | United States: Institutional Review Board |
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