Using inhaled amikacin to prevent pneumonia in cirrhosis patients on ventilators

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Anand V Kulkarni
• Email: anandvk90@gmail.com
• Phone: + 8553322434

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.