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Study on the role of inhaled antibiotic Amikacin in preventing respiratory infections in patients with liver disease

Inhaled Amikacin as a prophylaxis for Ventilator associated pneumonia in patients with cirrhosis: A Randomized placebo controlled double blind study - NIL

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/12/078033
Enrollment
162
Registered
2024-12-12
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K77- Liver disorders in diseases classified elsewhere

Interventions

Intervention1: Amikacin: 20MG/KG/day of amikacin will be administered as nebulization for 3 consecutive days after inclusion. Control Intervention1: Normal saline (Placebo): Equal volume of normal sal

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients admitted with liver disease to the liver ICU with hepatic encephalopathy (Grade 2 or higher), requiring intubation for at least 48 hours, without pneumonia.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Incidence of Ventilator associated pneumoniaTimepoint: Day 4, 7

Secondary

MeasureTime frame
All-cause in-hospital mortalityTimepoint: At day 28

Countries

India

Contacts

Public ContactDr Anand V Kulkarni

AIG Hospitals

anandvk90@gmail.com08553322434

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026