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

Indonesia University1 site in 1 country205 target enrollmentDecember 2012

ConditionsSepsis

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Sepsis
Sponsor: Indonesia University
Enrollment: 205
Locations: 1
Primary Endpoint: mortality rate
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2012

End Date

April 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Indonesia University

Responsible Party

Principal Investigator

Dana Dharaniyadewi

student

Indonesia University

Eligibility Criteria

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

Outcomes

Primary Outcomes

mortality rate

Time Frame: 14 days

mortality in 14 days since the patients were included in this study

Secondary Outcomes

the timing of empirical antibiotic first dose(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)