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

RecruitingPhase 4Ages 18 Years - anyAllAsian Institute of Gastroenterology, India
NCT06808074 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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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📋 Eligibility rules (as published)
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.
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What it tests

  • Inhaled amikacin
  • Placebo
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Where

2 sites
AIG Hospitals
Hyderabad, India
Asian Institute of Gastroenterology
Hyderabad, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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