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- Essai clinique NCT02121470
NGAL As An Aid for the Diagnosis of Acute Kidney Injury in Intensive Care
The NGAL Test™ As An Aid for the Diagnosis of AKI in an Intensive Care Population, US
Acute Kidney Injury (AKI) is a common and severe complication in critically ill patients which is associated with increased morbidity and mortality as well as high costs of medical care.
NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is a biomarker, that is expressed in several tissues including the kidneys. Renal expression of NGAL is dramatically increased in kidney injury from a variety of causes, and NGAL is released into both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early and sensitive biomarker of kidney injury, with the potential to assist clinicians in managing patients at risk of kidney injury.
This study is designed to validate the assigned NGAL cutoff value by comparing to clinical diagnosis of AKI as determined by current clinical practice in the US.
The study sites will enroll consecutive ICU patients. Patients are given standard clinical care and lab-work. Each day, one additional urine and two additional plasma samples will be drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL measurements.
The duration of each subject´s participation will be until discharge from the ICU, or for a maximum 8 days, whichever comes first. In addition serum creatinine values will continue to be collected manually from the hospital data system for 48 hours after discharge from the ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while the patient is still in the ICU).
250 subjects will be enrolled in total at the three investigator sites. At least 40 patients must be enrolled at each site.
The NGAL value will be matched to the "clinical diagnosis" of acute kidney injury (AKI) as specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values.
A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as assigned by the majority of the adjudication panel will be conducted.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
AKI is a common and severe complication in critically ill patients, which is associated with increased morbidity and mortality as well as high costs of medical care.
Despite efforts to standardize the definition and classification of AKI, there is still inconsistency in the application of the criteria and the limitations of serum creatinine and urine output for detecting AKI is generally recognized by the medical community. In the future, biomarkers of renal cell injury may identify additional patients with AKI and may identify the majority of patients at an earlier stage.
NGAL (neutrophil gelatinase-associated lipocalin, lipocalin-2, siderocalin) is such a biomarker. It is a small protein expressed in neutrophils and certain epithelia, including the renal tubules. Renal expression of NGAL is dramatically increased in kidney injury from a variety of causes, and NGAL is released into both urine and plasma. NGAL levels rise within two hours of the insult, making NGAL an early and sensitive biomarker of kidney injury.
Due to the heterogeneous implementation of AKI definitions and classifications, a uniform definition will be applied to this investigation, to ensure comparative results between the enrollment sites.
The aim of the study is to validate the assigned NGAL cutoff value by comparing to clinical diagnosis of AKI as determined by current clinical practice in the US.
The study sites will enroll consecutive patients meeting the criteria below in an ICU or critical care setting. Patients are given standard clinical care and lab-work. Each day, one additional urine and two additional plasma samples will be drawn and frozen. These additional samples are shipped to Sponsor for retrospective NGAL measurements.
The duration of each subject´s participation will be until discharge from the ICU, or for a maximum 8 days, whichever comes first. In addition serum creatinine values will continue to be collected manually from the hospital data system for 48 hours after discharge from the ICU. (If subject has been in ICU for 8 or more days, the follow up values are collected while the patient is still in the ICU).
250 subjects will be enrolled in total at the three investigator sites. At least 40 patients must be enrolled at each site.
The NGAL value will be matched to the "clinical diagnosis" of acute kidney injury (AKI) as specified by KDIGO® guidelines. The clinical diagnosis will be assigned by a three-person adjudication panel based on the entries in the eCRF by the investigators. Adjudicators are blinded for investigation site, AKI-diagnosis by treating physician, and NGAL values.
A comparison of AKI diagnosis based on the cutoff value 250 ng/mL and clinical diagnosis as assigned by the majority of the adjudication panel will be conducted.
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Primary endpoints:
- Sensitivity of the NGAL test will be estimated as the proportion of patients with an observed NGAL value above or equal to 250 ng/ml among patients classified as having AKI, and.
- Specificity of the NGAL test will be estimated as the proportion of patients with an observed NGAL value below 250 ng/ml among patients classified as not having AKI
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Springfield, Massachusetts, États-Unis, 01199/01107
- Baystate Medical Center / WNERTA
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New York
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Bronx, New York, États-Unis, 10467
- Montefiore Medical Center
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Texas
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Houston, Texas, États-Unis, 77030
- Methodist Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Admission to intensive care unit
- Informed consent
- Age ≥ 18 years.
Exclusion criteria:
- History of nephrectomy, renal transplantation and/or renal replacement therapy initiated before admission
- Males and females aged 17 years or below
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
NGAL (ng/mL)
Délai: Daily during ICU stay up to 8 days
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Highest measured value used
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Daily during ICU stay up to 8 days
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Creatinine
Délai: Daily during ICU stay up to 8 days + 2 days after discharge
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Change from baseline/reference value calculated to be used in application of diagnostic AKI criteria and rating
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Daily during ICU stay up to 8 days + 2 days after discharge
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Urine output
Délai: 6h, 12h and 24h daily during ICU stay up to 8 days
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Urine output calculated (mL/kg/h) to be used in application of diagnostic AKI criteria and rating
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6h, 12h and 24h daily during ICU stay up to 8 days
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Peter A McCullough, M.D., St. John Providence Health System
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- KLIN 12-005
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Essais cliniques sur Lésion rénale aiguë
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Kessler FoundationInstituto Vocacional Enrique Díaz de León A.C., Guadalajara, MexicoRecrutementTBI (Traumatic Brain Injury) ou MS (Sclérose en Plaques)États-Unis, Espagne