- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01362920
Diagnostic and Prognostic Value of Serial Procalcitonin (PCT) Measurements in Critically Ill Patients (PCT)
Diagnostic and Prognostic Value of Serial PCT Measurements in Critically Ill Patients
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Procalcitonin (PCT) is a 116 amino acid peptide that has an approximate MW of 14.5 kDa and belongs to the calcitonin (CT) superfamily of peptides. Transcription of the CALC-1 gene for PCT is usually suppressed in the non-neuroendocrine tissue, except in the C cells of the thyroid gland where its expression produces PCT, the precursor of CT in healthy individuals and in the absence of infection.
In the presence of microbial infection, circulating levels of calcitonin precursors (CTpr), including PCT, increase up to several thousand-fold.1 In addition to being a marker of microbial infection, PCT also acts as a modulator of the host inflammatory reaction. In an animal model of sepsis, administration of exogenous human PCT worsened outcome, whereas neutralization of endogenous PCT improved survival.
There are several inflammatory laboratory markers, like tumor necrosis factor (TNF)-α, interleukin (IL)-1, IL-6 and C-reactive protein (CRP), but they are non- specific for infection and can be caused by conditions like pancreatitis, burns, trauma or acute lung injury. The non-specific nature of clinical and laboratory parameters for microbial infection makes it difficult to evaluate patients with potential infection. In addition to the lack of specificity, traditional laboratory and clinical indicators of sepsis are not temporally concordant with the course of illness. As a result, these tests are not reliable to evaluate the response to therapeutic interventions in real time.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic
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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:
- All consecutive patients admitted to the Medical Intensive Care Unit of the Cleveland Clinic with an anticipated MICU stay of ≥ 12hrs
Exclusion Criteria:
- Age less than 18-years of age and/or an expected MICU stay of less than 12-hrs
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cas-témoins
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Sepsis or Septic shock cohort
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Non-sepsis or non-Septic shock cohort
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Development of organ failure
Délai: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Development and resolution of shock using a cut-off PCT of >0.5ng/mL
Délai: ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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ICU stay (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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ICU and Hospital Mortality
Délai: current hospitalization or 28-day post ICU admission for ICU survivors
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current hospitalization or 28-day post ICU admission for ICU survivors
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
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Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Délai: Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Current hospitalization (participants will be followed for the duration of hospital stay; an expected average of 7-days)
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Jorge A Guzman, MD, The Cleveland Clinic
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
- PCT-001
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