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

Launched by ASIAN INSTITUTE OF GASTROENTEROLOGY, INDIA · Jan 29, 2025

Keywords

ClinConnect Summary

The clinical trial, titled "A Study to Evaluate the Role of Inhaled Amikacin to Prevent Ventilator-Associated Pneumonia in Patients with Cirrhosis," is exploring whether inhaling a medication called amikacin can help prevent a serious lung infection known as ventilator-associated pneumonia (VAP) in patients with cirrhosis who are in the intensive care unit (ICU). Patients with cirrhosis often face complications, including a higher risk of VAP, especially if they have a condition called hepatic encephalopathy, which affects brain function. This study aims to find out if using inhaled amikacin can reduce the chances of developing pneumonia in these patients, providing important information for healthcare providers.

To be eligible for the trial, participants must be at least 18 years old, admitted to the liver ICU with moderate to severe hepatic encephalopathy, and require a breathing machine (intubation) for at least 48 hours, but they should not have pneumonia at the time of enrollment. Patients will be monitored closely during the study to see how well the inhaled amikacin works in preventing pneumonia. This trial is important because it could offer new insights into treating vulnerable patients with cirrhosis and improve their chances of recovery.

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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.