Status:
UNKNOWN
Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients
Lead Sponsor:
Madonna Magdy Fahmy
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The aim of this study is to compare the efficacy and safety of colistin versus lactulose for secondary prophylaxis of overt hepatic encephalopathy in patients with liver cirrhosis.
Detailed Description
Hepatic encephalopathy (HE) is a reversible neuropsychiatric changes, it occurs in 30%-45% of cirrhotic patients during their life. Once HE is developed, the 1-year mortality exceeds 60%. The high mor...
Eligibility Criteria
Inclusion
- • Age \>18 years.
- Patients with liver cirrhosis and previous history of recovery from hepatic encephalopathy.
Exclusion
- • History of taking lactulose in past 7 days
- Patients on secondary prophylaxis for spontaneous bacterial peritonitis
- Patients on psychoactive drugs, such as antidepressants or sedatives
- Previous transjugular intrahepatic portosystemic shunts or shunt surgery
- Significant comorbid illness such as heart, respiratory, or neurological disease such as Alzheimer's disease and Parkinson's disease
- Hepatocellular carcinoma or other neoplasias that could shorten life expectancy
- Recent infection or antibiotic use within last 6 weeks
- Recent gastrointestinal bleeding in the past 6 weeks
- Renal insufficiency, myasthenia gravis.
- Hypersensitivity to colistin sulfate.
- Pregnancy or lactation
- Alcohol intake
Key Trial Info
Start Date :
March 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
316 Patients enrolled
Trial Details
Trial ID
NCT05279586
Start Date
March 1 2022
End Date
March 1 2023
Last Update
March 15 2022
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