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

Primary Purpose

Acute-On-Chronic Liver Failure, Hepatic Encephalopathy

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

eCRRT

About this trial

This is an interventional treatment trial for Acute-On-Chronic Liver Failure focused on measuring Acute-On-Chronic Liver Failure, Overt Hepatic Encephalopathy, Continuous Replacement Renal Therapy, Liver Transplantation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

eCRRT group

Control group

Arm Description

Initiated CRRT within the first 24 post-transplant hours.

Standard treatment.

Outcomes

Primary Outcome Measures

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.

Adverse events

Any adverse event which probable related with CRRT

Secondary Outcome Measures

Invasive ventilation days

The time period when patients breath with ventilator through artificial airway

ICU stay (days)

The time period from transplantation to first ICU discharge

Reintubation rate

Reintubation after the first extubation following liver transplantation

90 days mortality

All cause mortality

Infection rate

Any diagnosed infection after transplantation in 30 days

Full Information

NCT ID

NCT04317222

First Posted

March 19, 2020

Last Updated

March 20, 2020

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

1. Study Identification

Unique Protocol Identification Number

NCT04317222

Brief Title

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

Acronym

LTeCRRT

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

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

June 1, 2020 (Anticipated)

Primary Completion Date

May 31, 2022 (Anticipated)

Study Completion Date

August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute-On-Chronic Liver Failure, Hepatic Encephalopathy

Keywords

Acute-On-Chronic Liver Failure, Overt Hepatic Encephalopathy, Continuous Replacement Renal Therapy, Liver Transplantation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

eCRRT group

Arm Type

Experimental

Arm Description

Initiated CRRT within the first 24 post-transplant hours.

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Standard treatment.

Intervention Type

Device

Intervention Name(s)

eCRRT

Intervention Description

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

Primary Outcome Measure Information:

Title

Consciousness recovery time

Description

The period from post-transplant immediate to the time when the patient have the first spontaneous eye opening and proper motor response to commands.

Time Frame

From the immediate to 30 days after liver transplantation

Title

Adverse events

Description

Any adverse event which probable related with CRRT

Time Frame

From the immediate to 7 days after liver transplantation (CRRT therapy period)

Secondary Outcome Measure Information:

Title

Invasive ventilation days

Description

The time period when patients breath with ventilator through artificial airway

Time Frame

From the immediate to 30 days after liver transplantation

Title

ICU stay (days)

Description

The time period from transplantation to first ICU discharge

Time Frame

up to one year

Title

Reintubation rate

Description

Reintubation after the first extubation following liver transplantation

Time Frame

From the immediate to 30 days after liver transplantation

Title

90 days mortality

Description

All cause mortality

Time Frame

From the immediate to 90 days after liver transplantation

Title

Infection rate

Description

Any diagnosed infection after transplantation in 30 days

Time Frame

From the immediate to 30 days after liver transplantation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huimin Yi, doctor

Phone

18922102510

ylhmin@hotmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Haijin Lv, doctor

Phone

18922103230

haijinlv@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Huimin Yi, MD

Organizational Affiliation

The 3rd affiliated hospital of Sun Yat-sen University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

All the individual participant data (IPD) that underlie results in a publication will be shared with other researchers.

IPD Sharing Time Frame

One year from the time of result publication

IPD Sharing Access Criteria

Claim from Principle investigator by email. Need Curriculum Vitae.

Citations:

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

Results Reference

result

Learn more about this trial

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

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