Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF

• clinical/ biochemical improvement in liver function profile [ Time Frame: 2 months ] [ Designated as safety issue: No ]
• frequency of multi-organ failure [ Time Frame: 2 months ] [ Designated as safety issue: No ]

The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.

• Drug: Granulocyte Colony Stimulating Factor
  Dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.
• Drug: Normal Saline
  dose of 1ml s/c at days 1, 2, 3, 4, 5, and then every 3rd day till day 28 (total 12 doses) along with the standard therapy.

• Active Comparator: G-CSF group
  Patients with Acute on chronic liver failure after baseline investigations for the etiology of the acute event and the underlying chronic disease were given Granulocyte Colony Stimulating Factor therapy for a total duration of one month.
  Intervention: Drug: Granulocyte Colony Stimulating Factor
• Placebo Comparator: Placebo
  After baseline characterization and work up for underlying acute and chronic liver disease, patients were given placebo along with the standard therapy
  Intervention: Drug: Normal Saline

Inclusion Criteria:

• Patients with acute hepatic insult manifesting as jaundice (Sr. Bil. ≥5 mg/dL) and coagulopathy (INR≥1.5), complicated within 4 weeks by ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease.(APASL criteria)

Exclusion Criteria:

• HCC or portal vein thrombosis. Refusal to participate in the study. Sepsis ( Any culture positive: blood, urine, focus of infection on Xray chest, any other obvious source of infection: UTI, SBP) Multi organ failure. Grade 3 or 4 hepatic encephalopathy.