Cirrhosis, Hepatic Encephalopathy, Ventilator Associated Pneumonia (VAP)
Conditions
Keywords
Inhaled amikacin, Prophylaxis, Ventilator associated pneumonia
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.
Interventions
DRUGInhaled 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.
DRUGPlacebo
The equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days
Sponsors
Asian Institute of Gastroenterology, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Ventilator associated pneumonia | At day 7 and day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| All-cause in-hospital mortality | Day 28 |
| Incidence of Acute kidney injury | Day 7, 14, 28 |
Countries
India
Contacts
Primary ContactAnand V Kulkarni
Outcome results
None listed