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

Phase 4

Recruiting

• Conditions: Hepatic Encephalopathy; Cirrhosis; Ventilator Associated Pneumonia (VAP)
• Interventions: Drug: Inhaled amikacin; Drug: Placebo

• Registration Number: NCT06808074
• Lead Sponsor: Asian Institute of Gastroenterology, India

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-05
• Study Start: 2025-02-12
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2026-02
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Amikacin	Inhaled amikacin	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Incidence of Ventilator associated pneumonia	At day 7 and day 28

Secondary Outcome Measures

Name	Time	Method
All-cause in-hospital mortality	Day 28
Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)	Day 7, 14, 28
Time to resolution of Hepatic encephalopathy	Day 7, 14, 28
No. of ventilator free ICU days	Day 28
Incidence of Acute kidney injury	Day 7, 14, 28

Trial Locations

Locations (2)

AIG Hospitals; 🇮🇳 Hyderabad, Telangana, India

Asian Institute of Gastroenterology; 🇮🇳 Hyderabad, Telangana, India