Acute-On-Chronic Liver FailureLTeCRRTNCT04317222
Early Postoperative CRRT After Liver Transplantation in ACLF Patients With Overt HE
A study testing eCRRT in people with Acute-On-Chronic Liver Failure and Hepatic Encephalopathy, run by Third Affiliated Hospital, Sun Yat-Sen University.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure, Hepatic Encephalopathy
- What is being tested?
- eCRRT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Early Postoperative Continuous Renal Replacement Therapy After Liver Transplantation in Acute-on-chronic Liver Failure Patients With Overt Hepatic Encephalopathy
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.
Read the 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.
- Being tested
- eCRRT
- Keywords
- Acute-On-Chronic Liver Failure, Overt Hepatic Encephalopathy, Continuous Replacement Renal Therapy, Liver Transplantation
- Medical subject headings
- Acute-On-Chronic Liver Failure, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCRRTDevice
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
| Study group | Role | What they receive |
|---|---|---|
| eCRRT group | Experimental | Initiated CRRT within the first 24 post-transplant hours. Receives: Device: eCRRT |
| Control group | No intervention | Standard treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the immediate to 30 days after liver transplantation
Adverse events
Any adverse event which probable related with CRRT
Measured: From the immediate to 7 days after liver transplantation (CRRT therapy period)
Secondary outcomes (5)
Invasive ventilation days
The time period when patients breath with ventilator through artificial airway
Measured: From the immediate to 30 days after liver transplantation
ICU stay (days)
The time period from transplantation to first ICU discharge
Measured: up to one year
Reintubation rate
Reintubation after the first extubation following liver transplantation
Measured: From the immediate to 30 days after liver transplantation
90 days mortality
All cause mortality
Measured: From the immediate to 90 days after liver transplantation
Infection rate
Any diagnosed infection after transplantation in 30 days
Measured: From the immediate to 30 days after liver transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2020
- Study start1 Jun 2020 (estimated)
- Primary completion31 May 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huimin Yi, Third Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Huimin Yi, MD, Principal investigator, The 3rd affiliated hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317222
- Sponsor's protocol ID
- LTeCRRT-P1
- Acronym
- LTeCRRT
- Status last verified
- Mar 2020
- First submitted
- 19 Mar 2020
- Last updated
- 23 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All the individual participant data (IPD) that underlie results in a publication will be shared with other researchers.
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Postoperative Continuous Renal Replacement Therapy After Liver Transplantation in Acute-on-chronic Liver Failure Patients With Overt Hepatic Encephalopathy
- ClinicalTrials.gov ID
- NCT04317222
- Acronym / sponsor ID
- LTeCRRT / LTeCRRT-P1
- Keywords
- Acute-On-Chronic Liver Failure, Overt Hepatic Encephalopathy, Continuous Replacement Renal Therapy, Liver Transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 23 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| eCRRT group | Experimental | Device: eCRRTInitiated CRRT within the first 24 post-transplant hours. |
| Control group | No intervention | –Standard treatment. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCRRTeCRRT 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 | Device | eCRRT group |
Primary outcome
Consciousness recovery time
Time frame: From the immediate to 30 days after liver transplantation
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
Time frame: From the immediate to 7 days after liver transplantation (CRRT therapy period)
Any adverse event which probable related with CRRT
5 secondary outcomes
Invasive ventilation days
Time frame: From the immediate to 30 days after liver transplantation
ICU stay (days)
Time frame: up to one year
Reintubation rate
Time frame: From the immediate to 30 days after liver transplantation
90 days mortality
Time frame: From the immediate to 90 days after liver transplantation
Infection rate
Time frame: From the immediate to 30 days after liver transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2020.
- Results publicationYi 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
- Individual participant dataSharing planned: Yes. All the individual participant data (IPD) that underlie results in a publication will be shared with other researchers.
Related trials for Acute-On-Chronic Liver Failure
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruiting
Very Low-volume Plasma Exchange in ACLF
Acute on Chronic Liver Failure (ACLF)
Recruiting
A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
Acute-on-Chronic Liver Failure (ACLF), Liver Cirrhosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huimin Yi, MD principal investigator
The 3rd affiliated hospital of Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
A study testing eCRRT in people with Acute-On-Chronic Liver Failure and Hepatic Encephalopathy, run by Third Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huimin Yi, doctor (18922102510, ylhmin@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Consciousness recovery time (time frame: From the immediate to 30 days after liver transplantation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04317222, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2020.