Evaluation of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Early and Evolving Acute Kidney Injury (EVOLVE)
EValuation Of NGAL in Early and eVolving Acute kidnEy Injury
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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British Columbia
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Vancouver, British Columbia, Kanada
- University of British Columbia
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Colorado
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Denver, Colorado, Spojené státy
- St. Anthony's Central Hospital
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District of Columbia
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Washington, District of Columbia, Spojené státy
- George Washington University
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Maine
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Portland, Maine, Spojené státy
- Maine Medical Center
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Massachusetts
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Boston, Massachusetts, Spojené státy
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, Spojené státy
- Massachusetts General Hospital
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New York
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Albany, New York, Spojené státy
- St. Peters Healthcare
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Brooklyn, New York, Spojené státy
- New York Methodist
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Ohio
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Cleveland, Ohio, Spojené státy
- Cleveland Clinic Foundation
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy
- University of Pittsburgh
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Texas
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Houston, Texas, Spojené státy
- University of Texas, Houston
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
4.2.1 Inclusion Criteria
- Male or female scheduled for cardiovascular surgery (other than cardiac transplant) requiring cardiopulmonary bypass
- 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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Kohorty a intervence
Skupina / kohorta |
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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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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Emil Paganini, MD, The Cleveland Clinic
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- BSTE-0401
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