Health Condition 1: K703- Alcoholic cirrhosis of liver
Conditions
Interventions
Intervention1: Growth Hormone plus standard medical treatment: subcutaneous injection of 2IU per day for 1 month plus standard medical treatment
Control Intervention1: standard medical treatment: Stan
Sponsors
ICMR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Alcoholic hepatitis associated ACLF patients 2. Age 18-80 years 3. Availability of informed consent
Exclusion criteria
Exclusion criteria: 1. Hepatocellular carcinoma or active malignancy 2. Prior treatment with glucocorticoids and experimental therapies 3. Acute kidney injury, multi-organ failures ( >two) 4. Uncontrolled UGI-bleed 5. HIV infection and other confounding etiologies (HAV, HEV, HBV, HCV, Autoimmune hepatitis, Wilson disease, Hemochromatosis) 6. Pregnancy and lactation 7. CLIF-C ACLF score >60, AARC score >11, MELD >= 30 8. Uncontrolled infection or sepsis 9. Known hypersensitivity to GH or itâ??s adjuvants 10. Uncontrolled diabetes (Hb A1c >= 9) or diabetic retinopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on overall survival (Time frame 30 days)Timepoint: day 30 and 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on following clinical parameters - 1. Transplant free survival [Time frame: 30 and 90 days] 2. Disease severity (MELD, CLIF-C ACLF, MDF, and AARC scores) [Time frame: 30 and 90 days] 3. Evaluation of organ failures (number and type) [Time frame: 30 and 90 days] 4. Incidence of infections [Time frame: 30 and 90 days] 5. Length of hospital and ICU stay [Time frame: 30 and 90 days] Timepoint: Day 0, Day 30 and Day 90;Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on Treatment-related adverse eventTimepoint: Time frame (Day 30 and Day 90);Impact of GH along with standard medical therapy (SMT) as compared to SMT-alone on Metabolic pathways (through untargeted plasma proteomics followed by validation through ELISA)Timepoint: Day 0 and day 30;Impact of GH along with standard medical therapy (SMT) as compared to SMT alone on Serum GH and IGF-1 levelsTimepoint: Day 7 and day 30;Impact of GH along with standard medical therapy (SMT) as compared to SMT alone on Liver regeneration and cell deathTimepoint: Day 0 and Day 30;Impact of GH along with standard medical therapy (SMT) as compared to SMT on Bacterial translocationTimepoint: Day 0 and Day 30;Impact of GH along with standard medical therapy (SMT) as compared to SMT on select cytokine/chemokine profile (IL-6, 4, 10, TGF-beta, TNF-alpha & IFN-ɤ)Timepoint: Day 0 and day 30 | — |
Countries
India
Contacts
Public ContactNipun Verma
Postgraduate Institute of Medical Education and Research, Chandigarh, India
Outcome results
None listed