Kidney Failure, Acute Clinical Trial
Official title:
EValuation Of NGAL in Early and eVolving Acute kidnEy Injury
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.
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.
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Observational Model: Cohort, Time Perspective: Prospective
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