Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure

NCT04013113 | Unknown

• 1 other identifier: ILBS-ACLF-03
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

The study is done with the aim of finding the association between the bilirubin and bile acids / DAMPS molecule with organ failures and sepsis in the patients with acute on chronic liver failure . in this study there are 2 parts in the first part people who satisfy the eligibility criteria will be recruited and blood samples will be taken and above mentioned molecules will be analyzed and association ,if any with occurrences of organ failures / new onset sepsis will be analyzed . In the second part of the study the patients who meet the criteria will be randomized to either receive standard medical therapy or with either haemoperfusion or therapeutic plasma exchange with standard medical therapy . blood samples will be taken and stored, bile acids (primary and secondary bile acids, bilirubin and damps molecules will be analysed .the patients are followed for 90 days , then statistical analysis will be done to find the association with organ failures and new onset sepsis .

Conditions

Acute-On-Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Transplant free survival in all the group

  day 28

Secondary Outcomes (7)

• Development of organ dysfunction in all the group

  Day 7

• Development of organ dysfunction in all the group

  Day 15

• Development of organ dysfunction in all the group

  Day 28

• New onset of sepsis in ll the groups

  Day 7

• New onset of sepsis in ll the groups

  Day 15

Study Arms (3)

Standard Medical Treatment

ACTIVE COMPARATOR

Group A will be given standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Drug: Standard Medical Treatment

Hemoadsorption plus standard medical therapy

EXPERIMENTAL

Drug: Haemoperfusion; Drug: Standard Medical Treatment

Plasma Exchange plus standard medical therapy

EXPERIMENTAL

Drug: Standard Medical Treatment; Other: Plasma Exchange

Interventions

Haemoperfusion DRUG

Three sessions of Hemoperfusion, 1 plasma volume/session will be done to the selected patients. Hemoperfusion will be done through bile acids and ammonia filters to adsorb bile acids and ammonia respectively. Group specific fresh frozen plasma will be transfused to the patient through a peripheral vein catheter to prevent hypotension if required.

Hemoadsorption plus standard medical therapy

Standard Medical Treatment DRUG

Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.

Hemoadsorption plus standard medical therapy; Plasma Exchange plus standard medical therapy; Standard Medical Treatment

Plasma Exchange OTHER

Fresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved. The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier).

Plasma Exchange plus standard medical therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with ACLF as per APASL criteria will be included.
• Age : 18-65 yrs.

You may not qualify if:

• Patient with ischemic heart disease
• Patient with chronic obstructive disease.
• Patient with hepato cellular carcinoma.
• Patient with extra hepatic malignancy.
• Patient with chronic renal insufficiency.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Hemoperfusion; Plasma Exchange

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative; Blood Transfusion; Biological Therapy; Plasmapheresis; Blood Component Removal

Central Study Contacts

Dr Vinay Kumar, MD

CONTACT

01146300000; drvinaybr@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2019
• First Posted: July 9, 2019
• Study Start: July 9, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

IN (1)