Role of Standard Volume Plasma Exchange in Acute Liver failure: Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009525

Enrollment

Registered

2017-08-29

Start date

Unknown

Completion date

Unknown

Last updated

2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute Liver Failure

Interventions

Intervention1: Standard Volume Plasma Exchnage (SVPE) plus Standard of care: In this group patients will receive SVPE plus standard of care of management of ALF. Standard volume plasma exchange (SVPE)

Eligibility

Inclusion criteria

Inclusion criteria: 1. Written informed consent. 2. > 18 years of age 3. ALFED score

Exclusion criteria

Exclusion criteria: 1. Systolic blood pressure 2. ALFED score 5 or 6 at admission. 3. Lack of informed consent 4. Coexisting severe illness eg coronary artery disease, malignancy etc 5. Alcoholic hepatitis 6. Pregnant females 7. Post Liver Transplant patients

Design outcomes

Primary

Measure	Time frame
Effect of SVPE exchange on 30 day mortality in patients with ALF.Timepoint: 5 sessions of SVPE will be done on 5 consecutive days. SVPE will be discontinued in cases of improvement in hepatic encephalopathy or the development of shock or sepsis.	—

Secondary

Measure	Time frame
) To study the effect of high volume plasma exchange on SOFA score, quick SOFA and SIRS. 2) To study the effect of high volume plasma exchange on liver functions and coagulation parameters in ALF. 3) To study the effect of high volume plasma exchange on cytokine profile in ALF. 4) To study the incidence of infections and other complications in ALF patients undergoing high volume plasma exchange Timepoint: ) To study the effect of high volume plasma exchange on SOFA score, quick SOFA and SIRS at end of 28 days 2) To study the effect of high volume plasma exchange on liver functions and coagulation parameters in ALF at end of 28 days 3) To study the effect of high volume plasma exchange on cytokine profile in ALF at end of 28 days 4) To study the incidence of infections and other complications in ALF patients undergoing high volume plasma exchange at end of 28 days	—

Measure

Time frame

) To study the effect of high volume plasma exchange on SOFA score, quick SOFA and SIRS. 2) To study the effect of high volume plasma exchange on liver functions and coagulation parameters in ALF. 3) To study the effect of high volume plasma exchange on cytokine profile in ALF. 4) To study the incidence of infections and other complications in ALF patients undergoing high volume plasma exchange Timepoint: ) To study the effect of high volume plasma exchange on SOFA score, quick SOFA and SIRS at end of 28 days 2) To study the effect of high volume plasma exchange on liver functions and coagulation parameters in ALF at end of 28 days 3) To study the effect of high volume plasma exchange on cytokine profile in ALF at end of 28 days 4) To study the incidence of infections and other complications in ALF patients undergoing high volume plasma exchange at end of 28 days

—

Countries

India

Contacts

Public ContactDr Shalimar

All India Institute of Medical Sciences

drshalimar@yahoo.com9968405815

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026