Effect of Diluent Volume on Colistin Inhalation Therapy for Mechanically Ventilated Respiratory Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Drug concentration
研究概览
简要总结
The aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. The study aims to determine whether the diluent volume has an effect on clinical outcomes, including ICU length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. Additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. The findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.
详细描述
Background： Colistin is an antibiotic used to treat infections caused by multidrug-resistant Gram-negative bacteria. In recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. Despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear.
Study Design： A single-center, prospective, randomized controlled trial.
Methods： The study plans to enroll 60 participants. Colistin inhalation therapy will be administered using a blocked stratified random allocation. The control group will receive colistin 6 MU diluted in 6 ml of normal saline (1 MU per 1 ml), while the experimental group will receive colistin 6 MU diluted in 12 ml of normal saline (1 MU per 2 ml). The dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 MU, administered every 8 hours, continuously for 7 days.
Effect： The investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. Based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Intensive Care Unit.
- •Age greater than 18 years and using a ventilator due to acute respiratory failure.
- •Requires inhalation colistin treatment as determined by the disease.
- •Sign the written informed consent form.
排除标准
- •Renal failure requiring renal dialysis.
- •Receiving both inhaled colistin and intravenous colistin treatments.
研究组 & 干预措施
Colistin 1 MU in normal saline 1 ml
1 MU of colistin in a total volume of 6 ml, diluted with a 1:1 ratio in normal saline (0.9%)
干预措施: Colistin 1 MU in normal saline 1 ml (Other)
Colistin 1 MU in normal saline 2 ml
1 MU of colistin in a total volume of 12 ml, diluted with a 1:2 ratio in normal saline (0.9%)
干预措施: Colistin 1 MU in normal saline 2 ml (Other)
结局指标
主要结局
Drug concentration
时间窗: One hour post inhalation therapy with colistin on the third day of treatment
Drug concentration in bronchoalveolar lavage fluid and blood
次要结局
未报告次要终点
研究者
Ke-Yun, Chao
Group leader of Respiratory Therapists
Fu Jen Catholic University