NCT01862185已完成3 期
Pengaruh Pemeriksaan Procalcitonin Semikuantitatif Terhadap Adekuasi Terapi Antibiotik Empirik Awal Dan Mortalitas Pada Pasien Sepsis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- mortality rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •post operative patient
- •trauma patient
- •have obtained prior antibiotic
- •refused to participate
结局指标
主要结局
mortality rate
时间窗: 14 days
mortality in 14 days since the patients were included in this study
次要结局
- 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)
研究者
Dana Dharaniyadewi
student
Indonesia University
研究点 (2)
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