High-Volume vs. Standard Plasma Exchange in Acute Liver Failure with Cerebral Edema
This study will observe if high-volume plasma exchange is more effective than standard plasma exchange in reducing cerebral edema in people with acute liver failure.
High Volume Therapeutic Plasma Exchange
+ Standard volume therapeutic plasma exchange
Brain Diseases+13
+ Brain Edema
+ Central Nervous System Diseases
Treatment Study
Summary
Study start date: December 1, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on comparing two different methods of plasma exchange in patients who have acute liver failure with brain swelling, a condition known as cerebral edema. The goal is to determine which method is safer and more effective: high-volume plasma exchange or standard-volume plasma exchange. These procedures are important because they might help reduce brain swelling and improve outcomes for patients with severe liver failure, which is a life-threatening condition. The study is crucial as it could lead to better treatment strategies and improve survival rates for people facing this serious medical issue. In the study, participants undergo a brain scan to assess the severity of brain swelling before starting treatment. They receive plasma exchange therapy through a machine that filters and replaces their blood plasma. The high-volume exchange involves replacing a larger amount of plasma compared to the standard volume. Patients are closely monitored for changes in brain swelling and other health markers during and after the treatment sessions. The study also includes routine tests like EEGs to check for seizures and uses medications like hypertonic saline and mannitol to manage brain swelling. If any adverse effects occur, treatments are adjusted accordingly. The overall aim is to find the best plasma exchange method to improve patient recovery and reduce complications.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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. Cerebral edema documented on CT-scan and arterial ammonia \>150 ug/dL Exclusion Criteria: 1. Age \<18 or \> 70 years 2. HCC 3. Active untreated Sepsis/DIC 4. Hemodynamic instability non-responsive to initial fluid resuscitation with norepinephrine \>0.1 ug/kg/min 5. Post-resection and malignancy related liver failure 6. Coma of non-hepatic origin 7. Patients with uncontrolled infection 8. Patients with pulmonary involvement with Pa02/Fio2 ratio below 200. 9. Patients with post renal obstructive AKI, AKI suspected due to glomerulonephritis, interstitial nephritis or vasculitis based on clinical history and urine analysis 10. Extremely moribund patients with an expected life expectancy of less than 24 hours 11. Pregnancy related liver failure 12. 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) 13. Refusal to participate in the study 14. Drug-induced ALF
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Institute of Liver & Biliary Sciences
New Delhi, IndiaOpen Institute of Liver & Biliary Sciences in Google Maps