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NCT Number: NCT06808074

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

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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Key information

Conditions

Hepatic Encephalopathy Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Cirrhosis Cross Infection Digestive System Diseases Disease Attributes Fibrosis Healthcare-Associated Pneumonia Hepatic Insufficiency Iatrogenic Disease Infections Liver Diseases Liver Failure Lung Diseases Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Ventilator-Associated Respiratory Tract Diseases Respiratory Tract Infections Ventilator Associated Pneumonia (VAP)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AIG Hospitals, Hyderabad, Telangana, India

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients admitted to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.
  • Patient is aged ≥18 years.
  • Written informed consent of the patient or a proxy.

Exclusion criteria

  • Suspected or confirmed Pneumonia at the day of inclusion.
  • Patients with Chronic kidney disease on maintenance hemodialysis
  • 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
  • Pregnancy or breast-feeding.
  • Clinical indication for systemic aminoglycoside therapy the day of inclusion: as deemed necessary by the clinician in charge.
  • Patients known to be allergic to aminoglycosides.
  • Patients who received intravenous Amikacin before 7 days of inclusion in this study.

Treatment and study plan

Inhaled amikacin

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

Drug

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

Primary outcomes

  1. Incidence of Ventilator associated pneumonia

    Time frame: At day 7 and day 28

Secondary outcomes

  1. All-cause in-hospital mortality

    Time frame: Day 28

  2. Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)

    Time frame: Day 7, 14, 28

  3. Time to resolution of Hepatic encephalopathy

    Time frame: Day 7, 14, 28

  4. No. of ventilator free ICU days

    Time frame: Day 28

  5. Incidence of Acute kidney injury

    Time frame: Day 7, 14, 28

Study contacts

Contact information is provided by the study sponsor or research team.

Anand V Kulkarni

CONTACT

[email protected]

+ 8553322434

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Official study title

Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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