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

3. august 2009 opdateret af: Biosite

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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

355

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • University of British Columbia
  • Forenede Stater
    • Colorado
      • Denver, Colorado, Forenede Stater
        • St. Anthony's Central Hospital
    • District of Columbia
      • Washington, District of Columbia, Forenede Stater
        • George Washington University
    • Maine
      • Portland, Maine, Forenede Stater
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, Forenede Stater
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Forenede Stater
        • Massachusetts General Hospital
    • New York
      • Albany, New York, Forenede Stater
        • St. Peters Healthcare
      • Brooklyn, New York, Forenede Stater
        • New York Methodist
    • Ohio
      • Cleveland, Ohio, Forenede Stater
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater
        • University of Pittsburgh
    • Texas
      • Houston, Texas, Forenede Stater
        • University of Texas, Houston

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patients undergoing CABG Surgery that are thought to have a risk of developing AKI during/after surgery.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
1
High Risk population for developing AKI during/after CABG surgery.
2
Medium Risk population for developing AKI during/after CABG surgery.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Biosite

Efterforskere

  • Ledende efterforsker: Emil Paganini, MD, The Cleveland Clinic

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2007

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. april 2009

Datoer for studieregistrering

Først indsendt

15. februar 2007

Først indsendt, der opfyldte QC-kriterier

7. marts 2007

Først opslået (Skøn)

9. marts 2007

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. august 2009

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2009

Sidst verificeret

1. august 2009

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • BSTE-0401

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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