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Immune Profile, Neuronal Dysfunction, Metabolomics and Ammonia in Therapeutic Response of HE in ACLF

NCT05421351 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 135

Last updated 2023-05-03

No results posted yet for this study

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 recovery after an episode of overt HE. The evolution and pathogenesis of HE is well described in ALF and cirrhosis, but the dynamic changes in HE in ACLF in response to therapy such as ammonia reduction measures, antibiotics to target sepsis and inflammation, measures to alter dysbiosis such as probiotics or fecal microbiota transplant, and measures to target immune dysfunction such as steroids in alcohol-associated hepatitis. The central role of ammonia in the pathogenesis of HE in ACLF has been challenged by recent data. The approach to HE in ACLF has now refocused on systemic and neuro-inflammation, gut dysbiosis, immune dysregulation, and multi-omics approach. Most importantly, the modulation of the metabolome in response to therapy and interventions, and the use of sedatives, paralytic agents, antibiotics etc. in ACLF with HE in a real-world setting has not been reported.

Conditions

  • Hepatic Encephalopathy
  • Acute-On-Chronic Liver Failure
  • Decompensated Cirrhosis

Sponsors & Collaborators

  • Post Graduate Institute of Medical Education and Research, Chandigarh

    lead OTHER

Principal Investigators

  • Dr Madhumita Premkumar, DM · Post Graduate Institute of Medical Education and Research, Chandigarh

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-02
Primary Completion
2024-05-31
Completion
2025-05-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05421351 on ClinicalTrials.gov