- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01862185
The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients
Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
Sepsis is a serious clinical condition with a considerable morbidity and mortality. Procalcitonin (PCT) is a good biomarker for early diagnosis and infection monitoring. The present study aimed to investigate the effect of semi-quantitative PCT test to the empirical antibiotic initiation time, the appropriateness of empirical antibiotics and mortality in septic patients.
The hypothesis of the study are :
- There is an effect on mortality between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on empirical antibiotic initiation time between septic patients who do and do not do semi-quantitative PCT examination
- There is an effect on appropriateness of empirical antibiotic between septic patients who do and do not do semi-quantitative PCT examination
Study design is randomized diagnostic trial which is also a pragmatic trial.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
-
-
DKI Jakarta
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Jakarta, DKI Jakarta, Indonesien, 10430
- Cipto Mangunkusumo Hospital
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- aged more than 18 years old
- have at least two concomitant systemic inflammatory response syndrome criteria
- have focal infection
- with or without sign of organ hypoperfusion or dysfunction
Exclusion Criteria:
- post operative patient
- trauma patient
- have obtained prior antibiotic
- refused to participate
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: semi-quantitative procalcitonin
patients whom checked semi-quantitative procalcitonin examination
|
Andre navne:
|
Ingen indgriben: control
patients whom do not checked semi-quantitative procalcitonin examination
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
mortality rate
Tidsramme: 14 days
|
mortality in 14 days since the patients were included in this study
|
14 days
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
the timing of empirical antibiotic first dose
Tidsramme: in 24 hours since the patient was diagnosis as sepsis
|
when does the patient get their first dose of empirical antibiotic in 24 hours since the patient was diagnosis as sepsis?
|
in 24 hours since the patient was diagnosis as sepsis
|
the appropriateness of empirical antibiotic
Tidsramme: in 24 hours since the patient was diagnosed as sepsis
|
does the empirical antibiotic that given in 24 hours since the patient was diagnosis as sepsis is effective?
|
in 24 hours since the patient was diagnosed as sepsis
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Dana Dharaniyadewi, MD, Faculty of Medicine, Indonesia University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- AB-PCTQ1
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Kliniske forsøg med Sepsis
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University of Kansas Medical CenterUniversity of KansasRekrutteringSepsis | Septisk chok | Sepsis syndrom | Sepsis, svær | Sepsis bakteriel | Sepsis BakteriæmiForenede Stater
-
Jip GroenInBiomeRekrutteringMikrobiel kolonisering | Neonatal infektion | Neonatal sepsis, tidligt opstået | Mikrobiel sygdom | Klinisk sepsis | Kultur Negativ Neonatal Sepsis | Neonatal sepsis, sent opstået | Kultur Positiv Neonatal SepsisHolland
-
Karolinska InstitutetÖrebro University, SwedenAfsluttetSepsis | Sepsis syndrom | Sepsis, sværSverige
-
The University of QueenslandRoyal Brisbane and Women's HospitalUkendt
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Ohio State UniversityAfsluttetSepsis, Svær Sepsis og Septisk ShockForenede Stater
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Indonesia UniversityAfsluttetAlvorlig sepsis med septisk stød | Alvorlig sepsis uden septisk stødIndonesien
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Beckman Coulter, Inc.Biomedical Advanced Research and Development AuthorityRekrutteringAlvorlig sepsis | Alvorlig sepsis uden septisk stødForenede Stater
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Inverness Medical InnovationsAfsluttetSepsis | Systemisk inflammatorisk responssyndrom | Alvorlig sepsis | Sepsis syndromForenede Stater
Kliniske forsøg med semi-quantitative procalcitonin
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Erasmus Medical CenterAfsluttet
-
Consorci Sanitari de l'Alt Penedès i GarrafIkke rekrutterer endnu
-
Milton S. Hershey Medical CenterRekruttering
-
Centre Hospitalier Departemental VendeeAfsluttet
-
Cliniques universitaires Saint-Luc- Université...AfsluttetFebril neutropeni, lægemiddel-induceretBelgien
-
Karolinska University HospitalAfsluttetVærdien af procalcitonin hos patienter med mistanke om candidæmiSverige
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Central Hospital, Nancy, FranceAfsluttetBakteriæmi | Forurening | BlodkulturkontaminationFrankrig
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Rijnstate HospitalUkendtSepsis | ProcalcitoninHolland
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Aga Khan UniversityAfsluttet
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CAMC Health SystemTrukket tilbageIntraventrikulær blødning | Intracerebral blødningForenede Stater