Acute-On-Chronic Liver Failure, Hepatic Encephalopathy
Conditions
Keywords
Acute-On-Chronic Liver Failure, Overt Hepatic Encephalopathy, Continuous Replacement Renal Therapy, Liver Transplantation
Brief summary
Pretransplant hepatoencephalopathy (HE) markedly impacts recipient outcomes after liver transplantation. Intraoperative CRRT showed benefits but feasibility was much concerned. This study aims to observe the effect on consciousness recovery when initiating CRRT early in the post-transplant period in recipients with ACLF and overt HE.
Detailed description
Hepatoencephalopathy (HE) is a common severe decompensation in end stage liver diseases and resulted to the need of liver transplantation (LT). Pretransplant HE markedly impacts recipient outcomes after liver transplantation. HE in acute on chronic liver failure (ACLF) is categorized to type C HE. Hyperammonemia and systemic inflammation have been reported to contribute its development. Continuous renal replacement therapy (CRRT) has been shown great benefits in ACLF patients with HE. Intraoperative CRRT in LT also showed benefits but feasibility was much concerned. Our preliminary retrospective data showed that early CRRT (eCRRT) after LT reduced consciousness recovery time, ventilation days and post-transplant infection rate. This open label, parallel randomized trial will observe the effect on consciousness recovery when initiating CRRT early (eCRRT) in the post-transplant period in recipients with ACLF and overt HE. The CRRT safety and ventilation days, infection, mortality and ICU stay will also be measured.
Interventions
DEVICEeCRRT
eCRRT was define as: 1. Initiated within the first 24 post-transplant hours; 2. High volume (35-50ml/kg) hemofiltration; 3. Continuous at least 12 hours per day for 3 days; 4. Standard treatment
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Liver transplant recipients who meet all of the following criteria will be enrolled 1. Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity (PTA)\<40%; 2. Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven classification; 3. HE associated with acute liver failure (Type A) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (Type C)
Exclusion criteria
1. Patients with a previous history of kidney-related diseases and glomerular filtration rate \<30 millilitre per minute; 2. Patients with acute renal failure need CRRT before transplantation; 3. Patients newly developed acute renal failure need CRRT at the time of randomization; 4. Retransplantation or multiple-organs transplantation; 5. Any ischemic or hemorrhagic stroke co-morbidity; 6. Hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors; 7. Extremely moribund patients with an expected life expectancy of less than 24 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Consciousness recovery time | From the immediate to 30 days after liver transplantation | The period from post-transplant immediate to the time when the patient have the first spontaneous eye opening and proper motor response to commands. |
| Adverse events | From the immediate to 7 days after liver transplantation (CRRT therapy period) | Any adverse event which probable related with CRRT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reintubation rate | From the immediate to 30 days after liver transplantation | Reintubation after the first extubation following liver transplantation |
| Invasive ventilation days | From the immediate to 30 days after liver transplantation | The time period when patients breath with ventilator through artificial airway |
| Infection rate | From the immediate to 30 days after liver transplantation | Any diagnosed infection after transplantation in 30 days |
| 90 days mortality | From the immediate to 90 days after liver transplantation | All cause mortality |
| ICU stay (days) | up to one year | The time period from transplantation to first ICU discharge |
Contacts
Primary ContactHuimin Yi, doctor
Backup ContactHaijin Lv, doctor
Outcome results
None listed