Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia in Cirrhosis Patients with Hepatic Encephalopathy: A Randomized Placebo-Controlled Double-Blind Study

What this Trial Is About

Researchers are evaluating the use of inhaled amikacin to prevent ventilator-associated pneumonia (VAP) in patients with cirrhosis who have hepatic encephalopathy (HE) and require intensive care. Cirrhosis patients with HE are at high risk of developing VAP, which is linked to increased mortality despite standard care and antibiotics. This study aims to provide evidence-based guidance on using inhaled amikacin as a preventive treatment in this vulnerable patient group. The study compares inhaled amikacin with a placebo in patients admitted to a liver ICU who have HE grade 2 or higher and need intubation for at least 48 hours. Participants will receive either inhaled amikacin at 20 mg/kg (up to 2 g) once daily for three consecutive days or a saline placebo in the same schedule. This randomized, placebo-controlled, double-blind study is designed to assess the effect of inhaled amikacin on preventing pneumonia and other infections. Participants will be monitored throughout their ICU stay with evaluations at days 7, 14, and 28. Researchers will measure the incidence of ventilator-associated pneumonia, infections at other sites, time to resolution of hepatic encephalopathy, ventilator-free ICU days, and occurrence of acute kidney injury. The study also tracks all-cause in-hospital mortality at 28 days. Safety and outcome data will be carefully collected to understand the potential impact of inhaled amikacin on this patient population.

A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis