The Effect of Semi-quantitative Procalcitonin Assay to The Adequacy of Empirical Antibiotics and Mortality in Septic Patients

Study Overview
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Brief Summary
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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.

Official Title
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Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Other: semi-quantitative procalcitonin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: semi-quantitative procalcitonin<br>patients whom checked semi-quantitative procalcitonin examination | Other: semi-quantitative procalcitonin<br> <br> * Other names: PCT-Q;|
| No Intervention: control<br>patients whom do not checked semi-quantitative procalcitonin examination | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | mortality in 14 days since the patients were included in this study | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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semiquantitative, procalcitonin, sepsis, antibiotics, mortality