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Taking peoplePhase 4

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

Key facts

Phase
Phase 4

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Trial details

Who runs it
Asian Institute of Gastroenterology, India
Trial code
NCT06808074
Record updated
4 April 2025
Original description
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.Read full original descriptionShow less

Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study

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.

Inclusion: 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.

Exclusion: Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge; Patients who received intravenous Amikacin before 7 days of inclusion in this study; 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; Patients known to be allergic to aminoglycosides; Suspected or confirmed Pneumonia at the day of inclusion; Pregnancy or breast-feeding.

ClinicalTrials.gov NCT06808074