Health Condition 1: K758- Other specified inflammatory liverdiseases
Conditions
Interventions
Intervention1: Group A
Plasma Exchange followed by Corticosteroids: Therapeutic Plasma Exchange: Standard volume plasma exchange using the centrifugation method. Schedule is 3-5 sessions within 7 10 d
Sponsors
Department of Hepatology PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 18 or older. Confirmed diagnosis of AVH through compatible clinical signs and serological confirmation Prolonged cholestasis is defined by all of the following: At least 3 weeks since symptom onset Total bilirubin levels more than and equal to 5 mg per deciliter with direct fraction more than and equal to 50 percent Alkaline phosphatase more than and equal to 2 times the upper limit of normal or Gamma Glutamyl transferase more than and equal to 2 times the upper limit of normal, and or ongoing moderate to severe itching that is more than and equal to 5 times the on a 0 to 10 NRS. INR less than 1.5 and absence of hepatic encephalopathy that is no acute liver failure. Ability to provide informed consent.
Exclusion criteria
Exclusion criteria: Preexisting liver disease including cirrhosis or chronic viral hepatitis. Clinical acute liver failure with INR more than and equal to1.5 with encephalopathy or acute on chronic liver failure. Uncontrolled sepsis or unstable hemodynamics or active gastrointestinal bleeding. Platelet count less than fifty thousand that cannot be corrected Fibrinogen less than hundred milligram per deci liter that cannot be corrected. Any contraindication to steroids or therapeutic plasma exchange including severe allergy to replacement fluids, heart failure etc. Immunosuppression or recent steroid use that is over ten mg prednisolone equivalent for more than seven days in the past month. Pregnancy or breastfeeding. Any other reasons deemed appropriate by the investigator that is inability to adhere to study protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The duration to resolution of cholestasis by 28 days, defined as either A reduction of more than and equal to 50 percent in total bilirubin from baseline and a pruritus NRS less than and equal to 3 for 48 hours or total bilirubin less than 3 milligram per deciliter whichever occurs first. Timepoint: 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Pruritus burden that is the area under the curve of daily NRS 0 to 10 from Days 1 to 14. Change in serum total bile acids & from baseline to Days 7 & 14. Time until ALP becomes less than two times the upper limit of normal & Gamma glutamyl transferase less than two times the upper limit of normal Timepoint: 4 weeks | — |
Countries
India
Contacts
Public ContactDr Sunil Taneja
Postgraduate Institute of Medical Education and Research
Outcome results
None listed