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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