Procalcitonin as a Sepsis Biomarker in Guiding Antibiotics Treatment Duration in Ventilator Associated Pneumonia in Neuro-ICU: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 48
- 主要终点
- To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
研究概览
简要总结
Using Procalcitonin Tests to reduce antibiotics duration in Neurosurgical patients with Ventilated Associated Pneumonia
详细描述
Patients who are more than 18 years old who are admitted to Neurosurgical ICU will be recruited 48hours after ventilation if matches criteria for ventilator associated pneumonia. Patients will be randomised into 2 groups. first group will be procalcitonin guided in addition to conventionally guided sepsis assessment (TWC, CRP, body temperature). second group is only conventionally guided sepsis assessment. in procalcitonin guided group, blood sample will be taken on Day 1 of recruitment and day 5. On day 5 , the procalcitonin level will be compared to recommendations in PRORATA trial. If procalcitonin level is below the level to withhold antibiotics, recommendation will be made to the primary physician to off the antibiotics. Another Procalcitonin level will be repeated on Day 7 to rule out reinfection. This study aims to compare the duration of antibiotics and length of ICU stay among the 2 groups.
This study will fill up the gap among the lack of datas in neurosurgical patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Patients admitted to Neuro-ICU & Trauma ICU
- •Patients aged >18 years old.
- •Ventilation for >48 hours
- •VAP and treated with antibiotics <24hours prior to inclusion in trial.
- •Patient with arterial line or central line
排除标准
- •Patients who are on antibiotics but not assumed or proven to have VAP
- •Expected short ICU stay (<3 Days)
- •Non-bacterial infections
- •Long term antibiotic treatment (transplant or chemotherapy patients, endocarditis, osteomyelitis)
- •Hospitalisation 48hours before enrolment
- •Severe immunosuppression
- •Pregnancy
- •Primary team's decision to continue antibiotics for 14 days prior to trial
- •DNAR or expected to die within 5 days
结局指标
主要结局
To compare the duration of antibiotics between PCT versus Standard of care guided stopping antibiotic
时间窗: 14 days
compare the duration of antibiotics between 2 arms
To compare the length of ICU stay in between PCT versus Standard of care guided stopping antibiotic
时间窗: 14 days
compare the length of ICU stay in between 2 arms
次要结局
- To compare 14 days mortality rate in between 2 arms(14 days)
- To compare the proportion of reinfection within 72 hours after stopping antibiotics(14 days)
- To compare proportion of difficult to treat organisms (MRO) in between 2 arms(14 days)
研究者
Mohd Zulfakar Mazlan, MBBS
Associate Professor Dr
Universiti Sains Malaysia