Early Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE (LTeCRRT)

Sun Yat-sen University

Status

Unknown

Conditions

Acute-On-Chronic Liver Failure

Hepatic Encephalopathy

Treatments

Device: eCRRT

Study type

Interventional

Funder types

Other

Identifiers

NCT04317222

LTeCRRT-P1

Details and patient eligibility

About

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.

Full 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.

Enrollment

250 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: Liver transplant recipients who meet all of the following criteria will be enrolled

Pre transplant liver failure: Total bilirubin over 171μmol/L and prothrombin activity (PTA)<40%;
Overt hepatic encephalopathy(HE): Grade II or higher HE according West Haven classification;
HE associated with acute liver failure (Type A) or cirrhosis complicated with portal hypertension and/or portal systemic shunts (Type C)

Exclusion Criteria:

Patients with a previous history of kidney-related diseases and glomerular filtration rate <30 millilitre per minute;
Patients with acute renal failure need CRRT before transplantation;
Patients newly developed acute renal failure need CRRT at the time of randomization;
Retransplantation or multiple-organs transplantation;
Any ischemic or hemorrhagic stroke co-morbidity;
Hemodynamic instability requiring fluid resuscitation or very high dose of vasopressors;
Extremely moribund patients with an expected life expectancy of less than 24 hours.