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

Acute-On-Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03162419
• Other study ID #: ILBS-ACLF-01
• Status: Withdrawn
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: April 25, 2019

Study information

• Verified date: June 2018
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 25, 2019
• Est. primary completion date: April 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Liver Failure

Intervention

Drug:
• Standard Medical Therapy
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.

Biological:
• Plasma Exchange
High volume plasma exchange sessions till a maximum of ten sessions.
• GCSF
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

Locations

Country	Name	City	State
India	Institute of Liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant free survival		28 days
Secondary	Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups		Day 14
Secondary	Improvement in biochemical parameter which is defined as > 20% reduction from baseline in both groups		Day 28
Secondary	Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups		Day 14
Secondary	Improvement in clinical parameters which is defined as > 20% reduction from baseline in both groups		Day 28
Secondary	Improvement in APACHEII (by 2 points )		2 years
Secondary	Improvement in MELD (by 2 points )		2 years
Secondary	Improvement in SIRS by 2 points		2 years
Secondary	Improvement in SOFA (by 2 points )		2 years
Secondary	Incidence of new onset sepsis and SIRS in both groups.		Day 28
Secondary	Side effects of therapy in both groups		2 years