Health Condition 1: K701- Alcoholic hepatitis
Conditions
Interventions
Intervention1: Combinatorial therapy: Rifaximin will be given orally 550mg twice daily per day for 30 days, Therapeutic plasma exchange will be done intravenous route, daily for 3-5 cycles over 3-5 da
Sponsors
PGIMER, Chandigarh
Eligibility
Inclusion criteria
Inclusion criteria: Severe Alcoholic hepatitis patients worsening or remaining static on standard medical therapy. aged 18 to 80 years, giving valid Informed consent
Exclusion criteria
Exclusion criteria: Hepatocellular carcinoma or active malignancy Portal vein thrombosis Spleen size more than 18cm Prior treatment with glucocorticoids Renal failure (creatinine more than or equal to 2 mg/dL) Mean arterial pressure less than 70 mm Hg or requirement of vasopressors PF ratio lesser than or equal to 200 or mechanically ventilated for respiratory failure Uncontrolled UGI-bleed within last 48 hrs HIV infection, chronic viral hepatitis (HBV and HCV) Autoimmune hepatitis, Wilson disease, hemochromatosis Macrophage activation syndrome Pregnancy CLIF-C ACLF score more than 60, AARC score more than or equal to 11 Uncontrolled infection or sepsis Known hypersensitivity to G-CSF, plasma, Albumin, Rifaximin Lack of informed consent Post liver transplant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survivalTimepoint: 30 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Disease severity (MELD, MDF scores)Timepoint: 30, 90 days;Evolution of organ failures (number and type)Timepoint: 30, 90 days;Incidence of infectionsTimepoint: 30, 90 days;Length of hospital and ICU stayTimepoint: 30, 90 days;Overall survivalTimepoint: 60, 90 days;Stem cell mobilisationTimepoint: day 5, day 10;Transplant free survivalTimepoint: 30, 90 days;Treatment-related adverse eventTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Ashwin P Vinod
Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh
Outcome results
None listed