Sepsis Clinical Trial
Official title:
Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
Verified date | March 2014 |
Source | Indonesia University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Indonesia: Ethics Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 205 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Indonesia | Cipto Mangunkusumo Hospital | Jakarta | DKI Jakarta |
Lead Sponsor | Collaborator |
---|---|
Indonesia University |
Indonesia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | mortality rate | mortality in 14 days since the patients were included in this study | 14 days | No |
Secondary | the timing of empirical antibiotic first dose | 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 | No |
Secondary | the appropriateness of empirical antibiotic | 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 | No |
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