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

NCT06808074 · tracked via the Priya Life Science India tracker

Sponsor

Asian Institute of Gastroenterology, India

Phase

Phase 4

Started

2025-02-12

Last updated

2025-04-04

Condition(s) studied

Hepatic EncephalopathyCirrhosisVentilator Associated Pneumonia (VAP)

Investigational drug(s) / intervention(s)

Inhaled amikacinPlacebo

Inhaled amikacin: Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.

Placebo: The equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia. 2. Patient is aged ≥18 years. 3. Written informed consent of the patient or a proxy. Exclusion Criteria: 1. Suspected or confirmed Pneumonia at the day of inclusion. 2. Patients with Chronic kidney disease on maintenance hemodialysis 3. 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 4. Pregnancy or breast-feeding. 5. Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge. 6. Patients known to be allergic to aminoglycosides. 7. Patients who received intravenous Amikacin before 7 days of inclusion in this study.

Primary outcome measure(s)

Incidence of Ventilator associated pneumonia — At day 7 and day 28

Trial sites (2)

Facility	City	Region	Status
AIG Hospitals	Hyderabad	Telangana	Recruiting
Asian Institute of Gastroenterology	Hyderabad	Telangana	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808074 on ClinicalTrials.gov ↗ ← All trials in India