Inhaled Amikacin as a Prophylaxis for Ventilator Associated Pneumonia in Patients With Cirrhosis: A Randomized Placebo Controlled Double Blind Study
Overview
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Asian Institute of Gastroenterology, India
- Enrollment
- 162
- Locations
- 2
- Primary Endpoint
- Incidence of Ventilator associated pneumonia
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Inhaled Amikacin
Intervention: Inhaled amikacin (Drug)
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of Ventilator associated pneumonia
Time Frame: At day 7 and day 28
Secondary Outcomes
- All-cause in-hospital mortality(Day 28)
- Incidence of infections at other sites (Intrabdominal, Blood stream, Urinary tract, Skin and soft tissue)(Day 7, 14, 28)
- Time to resolution of Hepatic encephalopathy(Day 7, 14, 28)
- No. of ventilator free ICU days(Day 28)
- Incidence of Acute kidney injury(Day 7, 14, 28)
Investigators
Anand Kulkarni
Consultant, Department of Hepatology
Asian Institute of Gastroenterology, India