Health Condition 1: K720- Acute and subacute hepatic failure
Conditions
Interventions
Intervention1: Daily plasma exchange with SMT: Maximum 3+1 sessions during a period of 7 days
Control Intervention1: Alternate day therapeutic plasma exchange with SMT: Alternate day therapeutic plasm
Sponsors
Institute of Liver and Biliary Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Wilson disease with New Wilson Index of = 11 and INR = 2.5 2. Children aged 3 years to 18 years
Exclusion criteria
Exclusion criteria: 1. Grade 3 or grade 4 hepatic encephalopathy 2. Septic shock 3. Disseminated intravascular coagulation 4. Marked hemodynamic instability requiring a high dose of vasopressors (norepinephrine more than 0.5 mcg per kg per min) 5. Any severe cardio-pulmonary pre-existing disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the reduction in NWI (New Wilson Index) between both groups at the end of three sessions of plasma exchange.Timepoint: 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of change in serum and urine copper levels on day 7 after initiation of plasmapheresis as compared to baseline in alternate versus daily plasma exchange group.Timepoint: Day 7;Comparison of overall and native liver survival at day 90 between the two groups.Timepoint: Day 90;Comparison of change in dialysate copper levels at the end of 3rd session between both groups.Timepoint: 1 week;Comparison of total number of sessions of plasma exchange between both groups as on day 28.Timepoint: Day 28;Comparison of various laboratory parameters at end of 3rd plasma exchange compared to baseline.Timepoint: 1 week;Comparison of serious adverse events as defined by CTCAE criteria in both the groups.Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Seema Alam
Institute of Liver and Biliary Sciences
Outcome results
None listed