drugset / Trial / NCT04013113

Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

NCT04013113

RandomizedParallel-groupOpen-labelTreatment

Summary

The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed . In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .

Timeline

Start
2019-07-09
Primary completion
2020-07-31
Completion
2020-07-31

Drugs

EvaluationDrugModalityDoseRoute
Background Albumin Protein / enzyme biologic
Background Lactulose Other / unclassified
Background Terlipressin Peptide

Indications