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

Phase 3

Completed

• Conditions: Sepsis
• Interventions: Other: semi-quantitative procalcitonin

• Registration Number: NCT01862185
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
semi-quantitative procalcitonin	semi-quantitative procalcitonin	patients whom checked semi-quantitative procalcitonin examination

Primary Outcome Measures

Name	Time	Method
mortality rate	14 days	mortality in 14 days since the patients were included in this study

Secondary Outcome Measures

Name	Time	Method
the timing of empirical antibiotic first dose	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?
the appropriateness of empirical antibiotic	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?

Trial Locations

Locations (1)

Cipto Mangunkusumo Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia