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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
162
Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days.
The equivalent volume of saline solution (0.9% sodium chloride \[NaCl\]) will be administered once daily for three consecutive days
AIG Hospitals
Hyderabad, Telangana, India
RECRUITINGAsian Institute of Gastroenterology
Hyderabad, Telangana, India
RECRUITINGIncidence of Ventilator associated pneumonia
Time frame: At day 7 and day 28
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
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