Combination of rifaximin, plasma exchange, and stem cell based therapy for severe alcoholic hepatitis
- Conditions
- Health Condition 1: K701- Alcoholic hepatitis
- Registration Number
- CTRI/2023/04/052118
- Lead Sponsor
- PGIMER, Chandigarh
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Severe Alcoholic hepatitis patients worsening or remaining static on standard medical therapy. aged 18 to 80 years, giving valid Informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survivalTimepoint: 30 days
- Secondary Outcome Measures
Name Time Method 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