A study to determine if a new therapy(Plasma Exchange) can help in recovery of Acute on chronic Liver failure.

Phase 2

Recruiting

• Conditions: Acute and subacute hepatic failure,

• Registration Number: CTRI/2022/01/039094
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

•      Liver transplant remains a limited resource and therefore there is unmet need for alternative therapies Persistent or incident hyperammonemia is more frequent in ACLF and is a risk factor for developing new onset organ failure and mortality. Therapeutic plasma exchange can lowers ammonia level in patients of ACLF and can improve survival over standard medical management.

•      Plasma exchange, by eliminating accumulated toxins (e.g., DAMPs) in ACLF can facilitate recovery of the failing liver and improvement in SIRS.

•      Replacement of the coagulation factors and other proteins and hence replacing the metabolic functions of the failing liver.

• PE also leads to immunomodulation like shift toward TH2 balance, suppression of IL2 and IFN – Y production, reduction of inflammatory cytokines – TNF alpha and IL – 8 and helps in improvement of SIRS.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-01
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 194

Inclusion Criteria

• 1.Written informed consent.
• 2.18 – 60 years of age 3.EASL-ACLF grade 1, 2 and 3.

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.	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).	2) To study the effect of PE on the resolution or development of organ failures in ACLF.

Trial Locations

Locations (1)

All India Institute of Medical Sciences; 🇮🇳 South, DELHI, India

All India Institute of Medical Sciences

🇮🇳South, DELHI, India

Dr Shalimar

Principal investigator

9868397211

drshalimar@gmail.com