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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Inhaled Amikacin | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inhaled amikacin | Drug | Dosage of amikacin: 20 mg/kg based on ideal body weight, with a maximal dose of 2 g, once daily for 3 consecutive days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Ventilator associated pneumonia | At day 7 and day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anand V Kulkarni | Contact | + 8553322434 | anandvk90@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AIG Hospitals | Recruiting | Hyderabad | Telangana | 500032 | India |
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| Placebo | Drug | The equivalent volume of saline solution (0.9% sodium chloride [NaCl]) will be administered once daily for three consecutive days |
|
| 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 |
| Asian Institute of Gastroenterology | Recruiting | Hyderabad | Telangana | 500032 | India |
|
| ID | Term |
|---|---|
| D006501 | Hepatic Encephalopathy |
| D005355 | Fibrosis |
| D053717 | Pneumonia, Ventilator-Associated |
| ID | Term |
|---|---|
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000077299 | Healthcare-Associated Pneumonia |
| D003428 | Cross Infection |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D007049 | Iatrogenic Disease |
| D020969 | Disease Attributes |
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