- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ohio
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Cleveland, Ohio, Estados Unidos, 44195
- Cleveland Clinic
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Control de caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Development of organ failure
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jorge A Guzman, MD, The Cleveland Clinic
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- PCT-001
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