Hepatic Encephalopathy Clinical Trial
Official title:
Therapeutic Efficacy of Oral PEG3350 Plus Lactulose Versus Lactulose Alone in Patients of Acute on Chronic Liver Failure With Overt Hepatic Encephalopathy: A Single Blind Prospective Randomized Controlled Study
it is a single blind randomised control study which aims to study the effect of PEG3350 in resolution of overt hepatic encephalopathy in patients of acute on chronic liver failure. this will be compared with the standard of care in the management of hepatic encephalopathy.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | August 20, 2020 |
Est. primary completion date | May 25, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Age 18-75 years. - Patients with ACLF with presence of hepatic encephalopathy > grade 2 as per WHC Exclusion Criteria: - Pregnant women or those who are suspected to be having acute fatty liver of pregnancy - Malarial hepatopathy, enteric hepatitis, or ischemic hepatitis. - Serum Na <125 mEq/litre - Gastrointestinal (GI) obstruction, ileus, or gastric retention - Bowel perforation - Toxic colitis or toxic megacolon - Structural brain lesions (as indicated by computed tomography imaging if available and confirmed by neurological exam) - Other causes of altered mental status (i.e. not meeting the definition of hepatic encephalopathy - Uncontrolled infection with hemodynamic instability requiring vasopressors. |
Country | Name | City | State |
---|---|---|---|
India | Postgraduate Institute of Medical Education and Research | Chandigarh |
Lead Sponsor | Collaborator |
---|---|
Postgraduate Institute of Medical Education and Research |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Improvement in survival. | to look for any survival benefit in experimental arm at 28 days and 90 days | At day 28 and day 90. | |
Primary | Improvement of encephalopathy by one or more grades. | to look for the degree of improvement in grade of HE in both experimental arm and lactulose arm. | 24 hours, 48 hours and 72 hours | |
Secondary | Reduction in ammonia levels during and at the end of 48 hours, 72 hours and lactulose administration | to extrapolate weather reduction of grade of HE correlates with reduction of ammonia levels | 24 hours, 48 hours and 72 hours | |
Secondary | Prolongation of time to death among non-survivors. | to analyse the difference in time to event(death) among non survivors in experimental arm | 30 days | |
Secondary | Prevention / reduction of cerebral edema | to look for any evidence of cerebral edema reduction by means of optic nerve sheath diameter | 72 hours | |
Secondary | Reduction of seizures frequency | to analyse if reduction of HEresults in reduction or prevention of seizure episodes in both arms | 30 days |
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