Clinical trial NCT04317222: Early Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE
Official title: Early Postoperative Continuous Renal Replacement Therapy After Liver Transplantation in Acute-on-chronic Liver Failure Patients With Overt Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute-On-Chronic Liver Failure
Hepatic Encephalopathy
Keywords: Acute-On-Chronic Liver Failure
Overt Hepatic Encephalopathy
Continuous Replacement Renal Therapy
Liver Transplantation
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Consciousness recovery time
timeFrame: From the immediate to 30 days after liver transplantation
measure: Adverse events
timeFrame: From the immediate to 7 days after liver transplantation (CRRT therapy period)
Secondary outcomes:
measure: Invasive ventilation days
timeFrame: From the immediate to 30 days after liver transplantation
measure: ICU stay (days)
timeFrame: up to one year
measure: Reintubation rate
timeFrame: From the immediate to 30 days after liver transplantation
measure: 90 days mortality
timeFrame: From the immediate to 90 days after liver transplantation
measure: Infection rate
timeFrame: From the immediate to 30 days after liver transplantation
Other outcomes:
Locations:
Study officials:
affiliation: The 3rd affiliated hospital of Sun Yat-sen University
name: Huimin Yi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi H, Lv H, An Y, Yi X, Wei X, Chen G (2015) Early Continuous Blood Purification(CBP) Deceased the Incidence of Pulmonary Infection after Liver Transplantation in Severe End-Stage-Liver-Disease Recipients With Hepatic Encephalopathy. Transplantation 99:201-201