Using inhaled amikacin to prevent pneumonia in cirrhosis patients on ventilators

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

This study is testing if inhaled amikacin can help prevent pneumonia in patients with cirrhosis who are on ventilators.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Asian Institute of Gastroenterology, India (Academic / other)
• Locations: 2 sites (Hyderabad, Telangana and 1 other locations)
• Trial ID: NCT06808074 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of inhaled amikacin in preventing ventilator-associated pneumonia (VAP) in patients with cirrhosis and hepatic encephalopathy who require intubation. Given the high incidence of VAP in this vulnerable population, the study aims to provide evidence-based guidance for prophylactic treatment. Participants will be randomly assigned to receive either inhaled amikacin or a placebo while being monitored for pneumonia development. The findings could significantly impact clinical practices in managing cirrhosis patients in intensive care settings.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with hepatic encephalopathy requiring intubation for at least 48 hours and without pneumonia.

Not a fit: Patients with existing pneumonia, severe kidney disease, or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could reduce the incidence of pneumonia and improve survival rates in cirrhosis patients requiring mechanical ventilation.

How similar studies have performed: Previous studies, such as the AMIKINHAL trial, have shown success with similar prophylactic approaches in ICU patients, indicating potential for this study's success.

Eligibility criteria

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.

Where this trial is running

Hyderabad, Telangana and 1 other locations

• AIG Hospitals — Hyderabad, Telangana, India (Recruiting)
• Asian Institute of Gastroenterology — Hyderabad, Telangana, India (Recruiting)

Study contacts

• Study coordinator: Anand V Kulkarni

Conditions Hepatic Encephalopathy; Cirrhosis; Ventilator Associated Pneumonia; Inhaled amikacin; Prophylaxis; Ventilator associated pneumonia