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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-12

Study Completion Date

2026-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Hepatic Encephalopathy Cirrhosis Ventilator Associated Pneumonia (VAP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Inhaled Amikacin

Group Type EXPERIMENTAL

Inhaled amikacin

Intervention Type DRUG

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No