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- Klinische proef 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
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Ohio
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Cleveland, Ohio, Verenigde Staten, 44195
- Cleveland Clinic
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Case-control
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
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Sepsis or Septic shock cohort
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Non-sepsis or non-Septic shock cohort
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Development of organ failure
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Development of hospital acquired infections (catheter related blood stream infection, development of multidrug resistant infections, ventilator associated pneumonia)
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Jorge A Guzman, MD, The Cleveland Clinic
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PCT-001
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