Status:
UNKNOWN
Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF
Lead Sponsor:
Post Graduate Institute of Medical Education and Research, Chandigarh
Conditions:
Hepatic Encephalopathy
Acute-On-Chronic Liver Failure
Eligibility:
All Genders
18-65 years
Brief Summary
There is very little data related to the natural history of disease from covert HE (MHE and grade 1 HE) to overt HE (grades II, III and IV) in ACLF, with implications on long-term neurological recover...
Detailed Description
Hepatic Encephalopathy (HE) is a neuropsychiatric disorder characterized by cerebral dysregulation due to hepatic metabolic dysfunction and/or porto-systemic shunting (PSS) resulting in bypass of port...
Eligibility Criteria
Inclusion
- 1 . Age 18-65 years 2. Either gender 3. Patients with ACLF (CANONIC definition) of any etiology with HE ≥grade 2 as per West-Haven Criteria
Exclusion
- Patients with structural brain lesions, stroke, diagnosed neurological disease or history of seizures and are on neuropsychiatric medications, like sedatives, antidepressants, or antiepileptic drugs.
- Severe preexisting cardiopulmonary disease.
- Patients with hepatocellular carcinoma or systemic malignancy.
- Post liver transplant patients.
- HIV/AIDS infection.
- Patients who are having active COVID-19 infection.
- Those who do not consent to participate in the study.
- Those who have TIPS or Porto systemic surgical shunt in situ.
Key Trial Info
Start Date :
October 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2025
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT05421351
Start Date
October 2 2022
End Date
May 1 2025
Last Update
May 3 2023
Active Locations (1)
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1
Postgraduate Institute of Medical Education and Research
Chandigarh, India, 160012