NCT04317222

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

March 23, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 19, 2020

Last Update Submit

March 20, 2020

Conditions

Acute-On-Chronic Liver FailureHepatic Encephalopathy

Keywords

Acute-On-Chronic Liver FailureOvert Hepatic EncephalopathyContinuous Replacement Renal TherapyLiver Transplantation

Outcome Measures

Primary Outcomes (2)

  • 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

  • Adverse events

    Any adverse event which probable related with CRRT

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

Secondary Outcomes (5)

  • Invasive ventilation days

    From the immediate to 30 days after liver transplantation

  • ICU stay (days)

    up to one year

  • Reintubation rate

    From the immediate to 30 days after liver transplantation

  • 90 days mortality

    From the immediate to 90 days after liver transplantation

  • Infection rate

    From the immediate to 30 days after liver transplantation

Study Arms (2)

eCRRT group

EXPERIMENTAL

Initiated CRRT within the first 24 post-transplant hours.

Device: eCRRT

Control group

NO INTERVENTION

Standard treatment.

Interventions

eCRRTDEVICE

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

eCRRT group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 99:201-201

    RESULT

MeSH Terms

Conditions

Acute-On-Chronic Liver FailureHepatic Encephalopathy

Condition Hierarchy (Ancestors)

Liver Failure, AcuteLiver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Huimin Yi, MD

    The 3rd affiliated hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Huimin Yi, doctor

CONTACT

18922102510ylhmin@hotmail.com

Haijin Lv, doctor

CONTACT

18922103230haijinlv@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator and the director of transplant intensive care unit

Study Record Dates

First Submitted

March 19, 2020

First Posted

March 23, 2020

Study Start

June 1, 2020

Primary Completion

May 31, 2022

Study Completion

August 31, 2022

Last Updated

March 23, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
Time Frame
One year from the time of result publication
Access Criteria
Claim from Principle investigator by email. Need Curriculum Vitae.