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

Not Applicable

• Conditions: Acute-On-Chronic Liver Failure
• Interventions: Drug: Standard Medical Treatment; Drug: Haemoperfusion; Other: Plasma Exchange

• Registration Number: NCT04013113
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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 .

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-07
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-05
• Study Start: 2019-07-09
• Study First Posted: 2019-07-09
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-10
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Medical Treatment	Standard Medical Treatment	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.
Plasma Exchange plus standard medical therapy	Standard Medical Treatment	-
Hemoadsorption plus standard medical therapy	Haemoperfusion	-
Hemoadsorption plus standard medical therapy	Standard Medical Treatment	-
Plasma Exchange plus standard medical therapy	Plasma Exchange	-

Primary Outcome Measures

Name	Time	Method
Transplant free survival in all the group	day 28

Secondary Outcome Measures

Name	Time	Method
Development of organ dysfunction in all the group	Day 28
New onset of sepsis in ll the groups	Day 28
Adverse Events in all the groups	Day 28

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India