Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated April 4, 2025 (before its estimated February 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-01-29; most recent amendment 2025-04-03.
Status change: Not Yet Recruiting → Recruiting 2025-02-12
Trial Details
NCT Number NCT06808074
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions Hepatic Encephalopathy, Cirrhosis, Ventilator Associated Pneumonia (VAP)
Enrollment 162 participants
Start Date 2025-02-12
Primary Completion 2026-02 (estimated)
Study Completion 2026-05 (estimated)
Updated on ClinicalTrials.gov 2025-04-04