The recent AMIKINHAL trial found 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 physicians. Due to the lack of randomized controlled trials (RCTs) on the prophylaxis of VAP in cirrhosis patients with HE, conducting this study is necessary to evaluate the efficacy of inhaled amikacin. The study results may provide evidence -based guidance for therapy in this patient population.
Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
Patient is aged ≥18 years.
Written informed consent of the patient or a proxy.
Suspected or confirmed Pneumonia at the day of inclusion.
Patients with Chronic kidney disease on maintenance hemodialysis
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
Pregnancy or breast-feeding.
Parallel
Inhaled amikacin
DrugDosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.
Placebo
DrugThe equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days
Incidence of Ventilator associated pneumonia
All-cause in-hospital mortality
Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)
Time to resolution of Hepatic encephalopathy
No. of ventilator free ICU days
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