Clinical trial NCT02718079: High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure
Official title: High-Volume Plasma Exchange Versus Standard Medical Treatment in Patients With Acute Liver Failure-A Prospective Randomized Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2016-03-24
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will be conducted on patients admitted to Department of Hepatology from Jan 2016 to Jan 2018 at Institute of Liver \& Biliary Sciences, New Delhi. Study group will comprise of patients with acute liver failure (ALF) who have no option for liver transplant (due to any reason) or have contraindications for liver transplant or have no prospective living donor and will be assessed for enrollment in the trial.


Eligibility criteria: Inclusion Criteria:

* Patients with acute liver failure defined as : Patients with jaundice which is complicated by encephalopathy and coagulopathy within 4 weeks of the onset of jaundice and without underlying chronic liver disease.

Exclusion Criteria:

* Age \<12 or \> 75 years
* Hepato-Cellular Carcinoma
* Active untreated Sepsis/DIC
* Any evidence of active bleed secondary to coagulopathy
* Hemodynamic instability requiring high dose of Vasopressors
* Coma of non-hepatic origin.
* Pregnancy
* Comorbidities associated with poor outcome (Extrahepatic neoplasia, severe cardiopulmonary disease defined by a New York Heart Association score \>3, or oxygen/steroid-dependent chronic obstructive pulmonary disease).
* Patients being taken up for liver transplant
* Refusal to participate in the study.

Primary outcomes:
measure: Survival in both groups.
timeFrame: 21 days
Secondary outcomes:
measure: Duration of Intensive Care Unit stay in both groups.
timeFrame: 21 days
measure: Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
timeFrame: 48 hours
measure: Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
timeFrame: day 5
measure: Improvement in SIRS (Systemic Inflammatory Response Syndrome) score.
timeFrame: day 7
measure: Improvement in SOFA (Sequential Organ Failure Assessment) score.
timeFrame: 48 hours
measure: Improvement in SOFA (Sequential Organ Failure Assessment) score.
timeFrame: day 5
measure: Improvement in SOFA (Sequential Organ Failure Assessment) score.
timeFrame: day 7
measure: Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
timeFrame: 48 hours
measure: Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
timeFrame: Day 5
measure: Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score.
timeFrame: Day 7
measure: Effect on systemic haemodynamics in both groups.
timeFrame: 24 hours
measure: Effect on systemic haemodynamics in both groups.
timeFrame: 48 hours
measure: Pro inflammatory cytokines profile in both groups.
timeFrame: 1 hour
measure: Serum Endotoxin levels in both groups.
timeFrame: 1 hour
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Rakhi Maiwall, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Maiwall R, Bajpai M, Singh A, Agarwal T, Kumar G, Bharadwaj A, Nautiyal N, Tevethia H, Jagdish RK, Vijayaraghavan R, Choudhury A, Mathur RP, Hidam A, Pati NT, Sharma MK, Kumar A, Sarin SK. Standard-Volume Plasma Exchange Improves Outcomes in Patients With Acute Liver Failure: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2022 Apr;20(4):e831-e854. doi: 10.1016/j.cgh.2021.01.036. Epub 2021 Jan 29.