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

NCT ID: NCT04317222

Last Updated: 2020-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2022-08-31

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.

Conditions

Acute-On-Chronic Liver Failure; Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

eCRRT group

Initiated CRRT within the first 24 post-transplant hours.

Group Type: EXPERIMENTAL

eCRRT

Intervention Type: DEVICE

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

Control group

Standard treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Huimin Yi

Principal Investigator and the director of transplant intensive care unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Huimin Yi, MD

Role: PRINCIPAL_INVESTIGATOR

The 3rd affiliated hospital of Sun Yat-sen University

Central Contacts

Huimin Yi, doctor

Role: CONTACT

ylhmin@hotmail.com

18922102510

Haijin Lv, doctor

Role: CONTACT

haijinlv@163.com

18922103230

References

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

Reference Type: RESULT

Other Identifiers

LTeCRRT-P1

Identifier Type: -

Identifier Source: org_study_id