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

Institute of Liver and Biliary Sciences, India

Status: Withdrawn

Conditions: Acute-On-Chronic Liver Failure

Treatments: Biological: GCSF; Drug: Standard Medical Therapy; Biological: Plasma Exchange

Study type: Interventional

Funder types: Other

Identifiers

NCT03162419

ILBS-ACLF-01

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 3 patient groups

Standard Medical Therapy

Active Comparator group

Description:

The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Treatment:

Drug: Standard Medical Therapy

Standard Medical Therapy + Plasma exchange + GCSF

Experimental group

Description:

The patients in group B shall be given GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28 along with alternate day high volume plasma exchange sessions till a maximum of ten sessions.

Treatment:

Biological: Plasma Exchange

Drug: Standard Medical Therapy

Biological: GCSF

Standard Medical Therapy + GCSF

Experimental group

Description:

The patients in this will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded. The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28

Treatment:

Drug: Standard Medical Therapy

Biological: GCSF