Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
NCT ID: NCT04013113
Last Updated: 2019-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
250 participants
INTERVENTIONAL
2019-07-09
2020-07-31
Brief Summary
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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 .
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Standard Medical Treatment
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
Haemoperfusion
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.
Standard Medical Treatment
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
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
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).
Interventions
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Haemoperfusion
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.
Standard Medical Treatment
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
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).
Eligibility Criteria
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Inclusion Criteria
2. Age : 18-65 yrs.
Exclusion Criteria
2. Patient with chronic obstructive disease.
3. Patient with hepato cellular carcinoma.
4. Patient with extra hepatic malignancy.
5. Patient with chronic renal insufficiency.
18 Years
65 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-ACLF-03
Identifier Type: -
Identifier Source: org_study_id
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