Overview

To Assess the Efficacy of High-Volume Plasma Exchange and GCSF Versus GCSF Alone in Patients of Acute on Chronic Liver Failure (ACLF).

Status:
Withdrawn
Trial end date:
2019-04-25
Target enrollment:
0
Participant gender:
All
Summary
Study design-Open label randomized controlled trial Study period-2 years Study population-All patients of ACLF admitted to ILBS for a period of two years from Feb 2017 to Dec 2018 All the patients of ACLF will receive standard medical therapy and will be randomized within 48 hours of admission into three groups after screening for exclusion and inclusion criteria.(1:2:2) Group A-Standard Medical Therapy only Group B-Standard Medical therapy + Plasma exchange + GCSF Group C-Standard Medical Therapy + GCSF
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Treatments:
Anti-Bacterial Agents
Lactulose
Lenograstim
Terlipressin
Criteria
Inclusion Criteria:

- All consecutive patients in age group of 18-70 years with acute on chronic liver failure
as defined by APASL criteria shall be included in the study.Only those patients who wish to
be enrolled in the trial shall be included in the study.

Exclusion Criteria:

1. Steroid eligible patients with severe alcoholic hepatitis

2. Cirrhosis of liver with previous history of decompensation

3. Patients with severe cardiopulmonary disease

4. Pregnancy

5. Human Immmunodeficiency Virus infection

6. Hepatocellular carcinoma or extrahepatic malignancy

7. Chronic renal insufficiency on treatment with haemodialysis

8. Uncontrolled bleed or patients in disseminated intravascular coagulopathy

9. Patient with expected survival of less than 48 hours

10. Patients with moderate-severe acute respiratory distress syndrome

11. Hemodynamic instability with noradrenaline requirement of more than >0.5ug/kg/min or
requirement of dual vasopressors

12. Patients with leukemoid reaction or total leucocyte count > 40,000/mm3

13. Patients diagnosed with Hemophagocytic Lymphohistiocytosis

14. Patients with known hypersensitivity to Granulocyte colony stimulating factor