Efficacy and safety of intravenous colistin plus nebulized colistin versus intravenous colistin alone in patients with clinically suspected ventilator-associated pneumonia: a single-centre prospective cohort study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Clinical Improvement in terms of - 1.decreased FiO2 (20% decreases from baseline)
研究概览
简要总结
the study hypothesizes that intravenous colistin plus nebulized colistin improves clinical outcomes in patients with clinically suspected ventilator associated pneumonia compared to intravenous colistin alone. the primary objective is to see effectiveness of intravenous colistin plus nebulized colistin in the form of favourable clinical outcomes as composite end points as follows - decreased Fio2, decreased PEEP, decreased secretions, total leukocyte count within normal range, pro-calcitonin levels 80% decrease from baseline.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged 18 years or older patients admitted to critical care unit for more than 48 hours patients clinically suspected with ventilator associated pneumonia patients who will be receiving intravenous colistin and/or nebulized colistin.
排除标准
- •patients who will be discharged, leave against medical advise patient who are re-admitted to ICU.
结局指标
主要结局
Clinical Improvement in terms of - 1.decreased FiO2 (20% decreases from baseline)
时间窗: at baseline (for comparison), at end of3rd day
2.decreased PEEP (3 cm of water decrease from baseline)
时间窗: at baseline (for comparison), at end of3rd day
3.total leukocyte count (within normal range as compared to baseline)
时间窗: at baseline (for comparison), at end of3rd day
4. decreased secretions or decrease in number of suctioning as compared to baseline
时间窗: at baseline (for comparison), at end of3rd day
4. procalcitonin levels less than 0.05mcg/litre or 80% decrease from baseline
时间窗: at baseline (for comparison), at end of3rd day
次要结局
- clinical improvement(baseline, seventh day)
- median length of ICU Stay(date of admission in ICU & date of discharge/death/transferred out from ICU)
- median length of mechanical ventilation(date of intubation & date of extubation)
- percentage of change in Clinical pulmonary infection score at admission & at completion of antibiotic therapy(at admission & after antibiotic therapy is completed)
- all cause ICU mortality(between date of admission at ICU & date of discharge/death/transferred out)
- incidence of AKI(baseline, 3rd day & 7th day)
- incidence of bronchospasm(after each instance of nebulization)
- culture conversion rate(baseline & after completing antibiotic therapy)
研究者
Manisha Maheshwari
All India Institute of Medical Sciences Raipur