NCT04317222

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

Early Postoperative Continuous Renal Replacement Therapy After Liver Transplantation in Acute-on-chronic Liver Failure Patients With Overt Hepatic Encephalopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute-On-Chronic Liver Failure
• Hepatic Encephalopathy

Interventions

Type	Name	Description
DEVICE	eCRRT	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

Timeline

• Start date: 2020-06-01
• Primary completion: 2022-05-31
• Completion: 2022-08-31
• First posted: 2020-03-23
• Last updated: 2020-03-23