Inhaled Amikacin as a prophylaxis for Ventilator associated pneumonia in patients with cirrhosis: A Randomized placebo controlled double blind study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 1
- 主要终点
- Incidence of Ventilator associated pneumonia
研究概览
简要总结
With the recent AMIKINHAL trial finding that prophylactic inhaled amikacin was effective in lowering the incidence of ventilator-associated pneumonia in ICU patients. Since aspiration is a common complication of cirrhosis patients with HE (7 out of 10 patients develop some type of HE) who are hospitalized to the liver ICU also have an elevated risk of Ventilator associated pneumonia. Despite supportive care and appropriate antimicrobial therapy pneumonia is linked to greater mortality in cirrhosis. This poses a significant challenge to the physicians. No randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE have been done. Therefore, Our investigation is necessary to evaluate the efficacy of inhaled amikacin to prevent VAP in cirrhosis patients with HE. The results of this study can help physicians choose therapies that are supported by evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients admitted with liver disease to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
排除标准
- •a.Suspected or confirmed Pneumonia at the day of inclusion.
- •b.Patients with Chronic kidney disease on maintenance hemodialysis c.Stage 2 or 3 Kidney Disease Improving Global Outcome (KDIGO) classification AKI the day of inclusion.
- •Patients undergoing renal replacement therapy or for whom decision has been made to initiate renal replacement therapy can be included whatever the KDIGO stage d.
- •Pregnancy or breast-feeding.
- •e.Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
- •f.Patients known to be allergic to aminoglycosides.
- •Patients who received intravenous Amikacin before 7 days of inclusion in this study.
结局指标
主要结局
Incidence of Ventilator associated pneumonia
时间窗: Day 4, 7
次要结局
- All-cause in-hospital mortality(At day 28)
研究者
Dr Anand V Kulkarni
AIG Hospitals