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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03162419
Other study ID # ILBS-ACLF-01
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


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
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