In this prospective randomized controlled trial Investigator aim to evaluate the impact of high versus standard volume plasma-exchange in patients with acute liver failure with cerebral edema and clinical outcomes. ALF who meet the inclusion and exclusion criteria within the first 12 hours will be randomized into two groups
Interventional - High-volume plasma exchange Active Comparator - Standard volume plasma exchange
Expected outcome of the project-.
1. Primary end points: Time to improvement in cerebral edema 2. Secondary end points:
To study the adverse events of therapy (volume overload, pulmonary complications, allergic reactions) etc.
Transplant-free survival at day 21
None
Age <18 or > 70 years
HCC
Active untreated Sepsis/DIC
Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine >0.1 ug/kg/min
Parallel
High Volume Therapeutic Plasma Exchange
Procedure/SurgeryExperimental- High Volume Therapeutic Plasma Exchange at (8 - 9 litres of plasma would be exchanged in each patient over 6 - 8 hours)
Standard volume therapeutic plasma exchange
Procedure/SurgeryActive Comparator - The standard volume strategy would be performed centrifugation technique with Plasma volume varying from 1.5 - 2.5 times the plasma - volume along with Standard Medical Treatment.
Time to improvement in cerebral edema
Time to improvement in Cerebral Edema defined as sustained reduction in ammonia with resolution of Hepatic encephalopathy.
To study the adverse events of therapy
Adverse Events- Pulmonary complications, allergic reactions, hypotension, etc
Transplant-free survival at day 21
Time to death and liver transplant will be recorded
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This trial is not recruiting at the moment. You can still explore other options:
