The effect of PEG in the treatment of hepatic encephalopathy
Phase 3
- Conditions
- Cirrhosis.Other and unspecified cirrhosis of liver
- Registration Number
- IRCT2015083117719N2
- Lead Sponsor
- Tehran University of Medical Sciences-Collaborative Office Between University,Industry and Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 48
Inclusion Criteria
Age 18 to 80 years old; Documented cirrhosis with any underlying etiology; Any grade of hepatic encephalopathy; Signed informed consent by patient or his/her LARs (if there is an imperfect level of consciousness)
Exclusion criteria: Acute liver failure that was defined as the onset of severe acute liver injury with encephalopathy and international normalized ratio (INR) of =1.5 in a patient without cirrhosis or preexisting liver disease; Altered mental status due to a diagnosis other than hepatic encephalopathy; Patient's or his/her LAR unwillingness to this trial; Hemodynamic instability which needs vasopressors for resuscitation; Pregnancy.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Severity of hepatic encephalopathy. Timepoint: At presentation and 24 h later. Method of measurement: HESA (Hepatic Encephalopathy Scoring Algorithm).
- Secondary Outcome Measures
Name Time Method Blood level of ammonia. Timepoint: At presentation and 24 h later. Method of measurement: Blood sampling.