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

Asian Institute of Gastroenterology, India

Status and phase: Enrolling; Phase 4

Conditions: Hepatic Encephalopathy; Ventilator Associated Pneumonia (VAP); Cirrhosis

Treatments: Drug: Inhaled amikacin; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06808074

AIG/IEC-BH&R 62/09.2024-04

Details and patient eligibility

About

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.

Enrollment: 162 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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162 participants in 2 patient groups, including a placebo group

Inhaled Amikacin

Experimental group

Treatment:

Drug: Inhaled amikacin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo