A study to determine if a new therapy(Plasma Exchange) can help in recovery of Acute on chronic Liver failure.
Phase 2
- Conditions
- Health Condition 1: K720- Acute and subacute hepatic failure
- Registration Number
- CTRI/2022/01/039094
- Lead Sponsor
- All India Institute of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Written informed consent.
2.18 – 60 years of age
3.EASL-ACLF grade 1 and 2
Exclusion Criteria
1.Systolic blood pressure < 90 mm Hg
2.Lack of informed consent
3.Coexisting severe illness e.g., coronary artery disease, malignancy etc
4.Post Liver Transplant patients
5.Pregnancy
7.Active infection- bacterial or fungal.
8.Hepatocellular carcinoma
9.Patient who dies within 48 hrs of admission
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To study the effect of Plasma Exchange (PE) on 28-day mortality in patients with ACLF.Timepoint: 28 days
- Secondary Outcome Measures
Name Time Method 1) To study the effect of PE on APASAL ACLF Research Consortium (AARC) score, CLIF-C ACLF score, Acute Physiology and Chronic Health Evaluation (APACHE) II, and Systemic Inflammatory Response Syndrome (SIRS). <br/ ><br>2) To study the effect of PE on the resolution or development of organ failures in ACLF. <br/ ><br>3) To study the effect of plasma exchange on cytokine profile which includes pro-inflammatory cytokines (INF-A2, INF-G, IL-12, IL-15, IL-17, MCP-3, IL-6, MCP-1, MIP -1A, MIP-1B, TNF-A, TNF-B, IL-8, RNTS, IP – 10, ETXN), anti-inflammatory cytokines (IL-2, IL-4, IL-5, IL-10, IL-1RA, IL-7), growth factors (EGF, FGF-2, TGF A, G-CSF, GM-CSF, PDGF), DAMPS (HMGB1), endotoxin in ACLF. <br/ ><br>4) To study the incidence of infections and other complications in ACLF patients undergoing plasma exchangeTimepoint: 1) 28 days <br/ ><br>2) 28 days <br/ ><br>3) 28 days <br/ ><br>4) 28 days <br/ ><br>