Actively Recruiting
A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis
Led by Asian Institute of Gastroenterology, India · Updated on 2025-04-04
162
Participants Needed
2
Research Sites
63 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
A Study to Evaluate Role of Inhaled Amikacin to Prevent Ventilator Associated Pneumonia in Patients With Cirrhosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients admitted to the liver ICU with hepatic encephalopathy Grade 2 or higher, requiring intubation for at least 48 hours, without pneumonia
- Age 18 years or older
- Written informed consent from the patient or a proxy
You will not qualify if you...
- Suspected or confirmed pneumonia at the day of inclusion
- Chronic kidney disease patients on maintenance hemodialysis
- Stage 2 or 3 KDIGO classification acute kidney injury at inclusion day, except patients undergoing or planned for renal replacement therapy
- Pregnancy or breastfeeding
- Clinical need for systemic aminoglycoside therapy at inclusion
- Known allergy to aminoglycosides
- Received intravenous amikacin within 7 days before inclusion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
AIG Hospitals
Hyderabad, Telangana, India, 500032
Actively Recruiting
2
Asian Institute of Gastroenterology
Hyderabad, Telangana, India, 500032
Actively Recruiting
Research Team
A
Anand V Kulkarni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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