- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04013113
Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
A Randomized Controlled Trial of Efficacy and Safety of Hemoperfusion or Plasma Exchange Compared to Standard Medical Therapy in Patients With Acute on Chronic Liver Failure
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 .
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dr Vinay Kumar, MD
- Phone Number: 01146300000
- Email: drvinaybr@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Recruiting
- Institute of Liver & Biliary Sciences
-
Contact:
- Dr Vinay Kumar, MD
- Phone Number: 01146300000
- Email: drvinaybr@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients diagnosed with ACLF as per APASL criteria will be included.
- Age : 18-65 yrs.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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 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.
|
EXPERIMENTAL: Hemoadsorption plus standard medical therapy
|
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.
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. |
EXPERIMENTAL: Plasma Exchange plus standard medical therapy
|
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.
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Transplant free survival in all the group
Time Frame: day 28
|
day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Development of organ dysfunction in all the group
Time Frame: Day 7
|
Day 7
|
Development of organ dysfunction in all the group
Time Frame: Day 15
|
Day 15
|
Development of organ dysfunction in all the group
Time Frame: Day 28
|
Day 28
|
New onset of sepsis in ll the groups
Time Frame: Day 7
|
Day 7
|
New onset of sepsis in ll the groups
Time Frame: Day 15
|
Day 15
|
New onset of sepsis in ll the groups
Time Frame: Day 28
|
Day 28
|
Adverse Events in all the groups
Time Frame: Day 28
|
Day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ILBS-ACLF-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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