Status
Unknown
Phase
Not applicable
Enrollment
250
Locations
1
Results
Not posted
Publications
0
Study 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 .
Interventions
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.
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.
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).
Timeline
First posted
Jul 9, 2019
Study start
Jul 9, 2019
Primary completion
Jul 31, 2020
Study completion
Jul 31, 2020
Results posted
Not reported
Registry updated
Jul 10, 2019
Outcomes
Transplant free survival in all the group
Time frame · day 28
Development of organ dysfunction in all the group
Time frame · Day 7
Development of organ dysfunction in all the group
Time frame · Day 15
Development of organ dysfunction in all the group
Time frame · Day 28
New onset of sepsis in ll the groups
Time frame · Day 7
New onset of sepsis in ll the groups
Time frame · Day 15
New onset of sepsis in ll the groups
Time frame · Day 28
Adverse Events in all the groups
Time frame · Day 28
Eligibility
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 locations
India. Showing up to 24 locations stored in the fast local snapshot.
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Publications
No PMID-linked publications were present in this registry snapshot.
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