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

Hepatic Encephalopathy Clinical Trial

— LTeCRRT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04317222
• Other study ID #: LTeCRRT-P1
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: August 31, 2022

Study information

• Verified date: March 2020
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Huimin Yi, doctor
• Phone: 18922102510
• Email: ylhmin[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: August 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-On-Chronic Liver Failure
• Brain Diseases
• End Stage Liver Disease
• Hepatic Encephalopathy
• Hepatic Insufficiency
• Liver Failure

Intervention

Device:
• eCRRT
eCRRT was define as: Initiated within the first 24 post-transplant hours; High volume (35-50ml/kg) hemofiltration; Continuous at least 12 hours per day for 3 days; Standard treatment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Third Affiliated Hospital, Sun Yat-Sen University

References & Publications (1)

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 99:20

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Consciousness recovery time	The period from post-transplant immediate to the time when the patient have the first spontaneous eye opening and proper motor response to commands.	From the immediate to 30 days after liver transplantation
Primary	Adverse events	Any adverse event which probable related with CRRT	From the immediate to 7 days after liver transplantation (CRRT therapy period)
Secondary	Invasive ventilation days	The time period when patients breath with ventilator through artificial airway	From the immediate to 30 days after liver transplantation
Secondary	ICU stay (days)	The time period from transplantation to first ICU discharge	up to one year
Secondary	Reintubation rate	Reintubation after the first extubation following liver transplantation	From the immediate to 30 days after liver transplantation
Secondary	90 days mortality	All cause mortality	From the immediate to 90 days after liver transplantation
Secondary	Infection rate	Any diagnosed infection after transplantation in 30 days	From the immediate to 30 days after liver transplantation