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

Institute of Liver and Biliary Sciences, India

Status: Unknown

Conditions: Acute-On-Chronic Liver Failure

Treatments: Other: Plasma Exchange; Drug: Haemoperfusion; Drug: Standard Medical Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04013113

ILBS-ACLF-03

Details and patient eligibility

About

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 .

Enrollment: 250 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Patient with ischemic heart disease
2. Patient with chronic obstructive disease.
3. Patient with hepato cellular carcinoma.
4. Patient with extra hepatic malignancy.
5. Patient with chronic renal insufficiency.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 3 patient groups

Standard Medical Treatment

Active Comparator group

Description:

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.

Treatment:

Drug: Standard Medical Treatment

Hemoadsorption plus standard medical therapy

Experimental group

Treatment:

Drug: Haemoperfusion

Drug: Standard Medical Treatment

Plasma Exchange plus standard medical therapy

Experimental group

Treatment:

Other: Plasma Exchange

Drug: Standard Medical Treatment