Acute Liver Failure
Conditions
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.
Interventions
BIOLOGICALPlasma Exchange
OTHERManagement of cerebral edema/intracranial hypertension:
OTHERTransfer to Intensive Care Unit
OTHERIntubation of trachea
OTHERAdministration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure
OTHERVolume Replacement
OTHERPressor Support
OTHERCorrection of metabolic parameters
DIETARY_SUPPLEMENTCorrection of nutrition
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival in both groups. | 21 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Intensive Care Unit stay in both groups. | 21 days | — |
| Improvement in SIRS (Systemic Inflammatory Response Syndrome) score. | 48 hours | — |
| Improvement in SOFA (Sequential Organ Failure Assessment) score. | 48 hours | — |
| Effect on systemic haemodynamics in both groups. | 24 hours | Effect is defined as resolution of SIRS (Systemic Inflammatory Response Syndrome). |
| Pro inflammatory cytokines profile in both groups. | 1 hour | — |
| Serum Endotoxin levels in both groups. | 1 hour | — |
| Improvement in APACHE II (Acute Physiology and Chronic Health Evaluation) score. | 48 hours | — |
Countries
India
Outcome results
None listed