Acute on Chronic Liver Failure Clinical Trial
Official title:
An Open-label Randomized Controlled Trial Comparing the Role of Therapeutic Plasma-exchange in Ameliorating Secondary Organ Dysfunctions in Patients With ACLF and Develop Biomarkers of Treatment Response
Rationale: Current understanding of the pathophysiology of ACLF suggests that unresolved injury, poor infection control, and liver regeneration result in persistent systemic inflammation and cytokine storm, which subsequently lead to systemic inflammatory response syndrome (SIRS) resulting in multiple organ failures, septic shock and deaths in ACLF. Nearly 74% of ACLF patients initially diagnosed without SIRS, sepsis, or organ failure developed SIRS by day 7 which increases the onset of secondary organ failure and sepsis with high short-term mortality. The emerging use of plasma exchange has shown some potential benefits in terms of dampening systemic inflammation and improvement of outcomes in some ACLF patients. However, there is currently no randomized controlled trial exploring the potential role in ameliorating secondary organ dysfunctions in patients with ACLF is not known. Hence in the current objective, we want to study the role of plasma exchange in the management of sec. organ failure in ACLF patients in a randomized controlled trial and identify the biomarker to access the treatment response to therapy.
Status | Not yet recruiting |
Enrollment | 190 |
Est. completion date | December 31, 2027 |
Est. primary completion date | December 31, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Patients with ACLF with AARC grade 2 or more with or without single secondary organ failure. Exclusion Criteria: 1. 1. Patients with age less than 18 years or more than 65 years 2. Patients with HVOTO or EHPVO 3. Hepatocellular carcinoma (beyond Milan) or any extrahepatic malignancy 4. Active bleed (mucosal or variceal) or severe coagulopathy (platelets <20,000 or INR>4) 5. Patients with refractory shock requiring norepinephrine >0.5ug/kg/min 6. Patients with retroviral infections 7. Pregnancy or active breastfeeding 8. Known severe cardiopulmonary diseases (structural or valvular heart disease, coronary artery disease, coronary pulmonary disease, chronic kidney disease) 9. Lack of informed consent |
Country | Name | City | State |
---|---|---|---|
India | Institute of Liver & Biliary Sciences | New Delhi | Delhi |
Lead Sponsor | Collaborator |
---|---|
Institute of Liver and Biliary Sciences, India |
India,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The AARC grading is done by AARC score the values of which vary from 5-15 , pts are divided into 3 grades i.e AARC score 5-7- grade 1, 8-10- grade 2, and AARC 11-15 as grade 3. Improvement in 1 grade is associated with 40% improvement in 28-day survival | the measure is an ordinal variable with 3 categories as above (grade 1, 2 and 3) derived from AARC score from 5-15 | 28 days | |
Secondary | Transplant-free survival at 28-days | 28 days | ||
Secondary | The impact of TPE on the progression or resolution of secondary organ failures at day 7, 14 and 28 | Each organ failure will be defined based on the definition as yes or no. Depending on if the patient improves or progresses the information will be collected and analyzed. | day 7, 14 and 28 | |
Secondary | the development of infection at day 7 and 14 in patients who had no infection | day 7 and day 14 | ||
Secondary | Duration of ICU and hospital stay | 28 days | ||
Secondary | The proportion of patients developing adverse events will be compared between the two groups | 7 days |
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