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Recruiting NCT06808074

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

Phase IV Interventional Hepatic Encephalopathy Cirrhosis Ventilator Associated Pneumonia (VAP)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Inhaled amikacin, Placebo.
Who it may be relevant to
Registry conditions: Hepatic Encephalopathy, Cirrhosis, Ventilator Associated Pneumonia (VAP). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Inhaled amikacin
    Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.
  • Drug Placebo
    The equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days

Primary outcome measures

  • Incidence of Ventilator associated pneumonia [Time frame: At day 7 and day 28]
Secondary outcome measures (5)
  • All-cause in-hospital mortality [Time frame: Day 28]
  • Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue) [Time frame: Day 7, 14, 28]
  • Time to resolution of Hepatic encephalopathy [Time frame: Day 7, 14, 28]
  • No. of ventilator free ICU days [Time frame: Day 28]
  • Incidence of Acute kidney injury [Time frame: Day 7, 14, 28]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Prevention

Study locations

India · 2 centers
  • AIG Hospitals — Hyderabad
  • Asian Institute of Gastroenterology — Hyderabad

Identifiers

NCT: NCT06808074 · AIG/IEC-BH&R 62/09.2024-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗