- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04555382
Combining CAF, L-FABP and NGAL as a Potentially Diagnostic Model for Acute Kidney Injury.
Association Between CAF, L-FABP and NGAL and the Occurence of Acute Kidney Injury : a Potential Diagnostic Model of Three Biomarkers.
Acute kidney injury was a common clinical complication, and many diseases were associated with a high risk of occurrence of AKI. We explored the clinical utility of serum CAF, L-FABP and NGAL by constructing a diagnostic model for identification of ICU patients at risk for AKI and distinguish different etiologies of AKI.
This observational cohort study included one hundred patients who had been in ICU from the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. Blood and urine samples were collected every 12 hours until 7 days. The time of staying with ICU less than 2 days were removed. CAF, L-FABP and NGAL was measured based on the platform of Chemiluminescent Immunoassay, and assessed the diagnostic value of the occurrence of AKI. By constructing an effective diagnostic model to provide effective clinical decision-marking for early intervention.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The observational cohort study included one hundred patients who were from the intensive care unit of the Second Affiliated Hospital of Zhejiang University School of Medicine between August 2020 and August 2022. AKI was defined according to the Kidney Disease Improving Global Outcomes (KDIGO) guidelines as renal function was suddenly decreased within 48 hours and serum creatinine increased at least 0.3mg/dL, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours. The staging criteria of AKI as follows: stage I means serum creatinine higher than baseline between 1.5times and 1.9 times, or serum creatinine increased at least 26.5μmol/L, or serum creatinine increased more than 1.5 times higher than baseline within 7 days, or urine volume less than 0.5mL/Kg per hour for 6 hours; stage II means serum creatinine higher than baseline between 2.0 times and 2.9 times, or urine volume less than 0.5mL/Kg per hour for 12hours; stage III means serum creatinine higher than baseline 3.0 times, or serum creatinine higher than baseline 353.6μmol/L, or started renal replacement therapy. Patients who stayed in the ICU for less than 24 hours and whose serum creatinine had increased above normal reference range on the first day of ICU were excluded.
Collecting the blood and urine samples of the patients regularly every twelve hours, centrifuging samples in 3000rpm for 5 minutes, freezing at -80℃, all patients' clinical information should be recorded by name, age ,sex, BMI index, hypertension, diabetes, cardiac disease, and so on. All patients have written informed contents and this study was approved by the Second Affiliated Hospital of Zhejiang University School of Medicine.NGAL, CAF and L-FABP was measured by chemiluminescent immunoassay with Robust i1000.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Zhejiang
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Hangzhou, Zhejiang, Chine
- Recrutement
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University
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Contact:
- Wang Weilin
- Numéro de téléphone: +86 0571 87783759
- E-mail: keyanlunli_zheer@163.com
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- the serum creatinine was increased above reference range at first when patients were included intensive care unit;
- renal dialysis and plasma exchange were never occured when patients were included in the study;
- patients who were included in the study stayed at two days in ICU.
Exclusion Criteria:
- patients who stayed in ICU for less than 24 hours;
- the serum creatinine was increased above reference range before ICU admission;
- kidney-related diseases were existed before ICU admission.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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AKI group
this group are included patients who have not occured acute kidney injury at first, however acute kidney injury are occured soon afterwards during the observation period.
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Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
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non-AKI group
this group are included patients who have not occured acute kidney injury during the observation period.
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Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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the concentration of CAF, L-FABP and NGAL
Délai: seven days after admission
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the concentration of CAF, L-FABP and NGAL of blood and urine samples of every patients are measured by Chemiluminescent Immunoassay
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seven days after admission
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Collaborateurs et enquêteurs
Les enquêteurs
- Chaise d'étude: Tao Zhihua, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-791
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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