- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Forhold
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
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Sepsis or Septic shock cohort
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Non-sepsis or non-Septic shock cohort
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Development of organ failure
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Jorge A Guzman, MD, The Cleveland Clinic
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PCT-001
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