Liver FailureRESOLVE-CNCT05740696
Registry Study for Optimal Management of Liver Failure in the Chinese Population
An observational study of Liver Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 14 sites in China.
Trial summary
Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Liver Failure
- What is being tested?
- ALF, SALF and ACLF
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 14 sitesChina
- Study dates
- 6 Jan 2023to 30 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receive guideline-based systemic therapy. The follow-up assessments will be performed at week 1, 2, 3, 4, 12, 24 and 48 or any time if there is a change in condition. All the patients receive routine biochemical tests and imaging examinations.
Who may be able to join
- Patients with a diagnosis consistent with liver failure and pre-liver failure:
- Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention;
- Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol/L);
- Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5.
Who cannot join
- An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
China14 sites, 14 recruiting
- Recruiting
Ankang Central Hospital
Ankang
Zicheng Jiang
- Not yet recruiting
Xiangya Hospital of Central South University
Changsha
Ruochan Chen
- Not yet recruiting
Hanzhong 3201 Hospital
Hanzhong
Yongmei Lin
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan
Yuchen Fan
- Not yet recruiting
First Hospital of Lanzhou University
Lanzhou
Xiaorong Mao
- Not yet recruiting
Weinan Central Hospital
Weinan
Hongbing Li
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Yingli He, M.D.,Ph.D, 0086-18991232863, heyingli2000@xjtu.edu.cn
Juan Li, M.D., 0086-18209272726, lijuan1996xx@163.com
- Not yet recruiting
Air Force Medical University Tangdu Hospital
Xi'an
Hong Du
- Not yet recruiting
Shaanxi provincial people's hospital
Xi'an
Yu Li
- Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an
Fanpu Ji, 15319435860
- Not yet recruiting
Xi 'an International Medical Center Hospital
Xi'an
Zhansheng Jia
- Recruiting
Xianyang Central Hospital
Xianyang
Wenxuan Zhao
- Not yet recruiting
The Affiliated Hospital of Yan'an University
Yanan
Na Liu
- Not yet recruiting
General Hospital of Ningxia Medical University
Yinchuan
Xiangchun Ding
About this study
Official title: Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)
Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.
- Conditions
- Liver Failure
- Being tested
- ALF, SALF, ACLF
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALFProcedure or surgery
Acute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks
SALFProcedure or surgery
The onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks
ACLFProcedure or surgery
On the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period
| Study group | Role | What they receive |
|---|---|---|
| ALF | acute liver failure Receives: Procedure: ALF | |
| SALF | subacute liver failure Receives: Procedure: SALF | |
| ACLF | acute-on-chronic liver failure Receives: Procedure: ACLF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
28-day survival rates without liver transplantation
Measured: 28-day
Overall survival
90-day survival rates without liver transplantation
Measured: 90-day
Secondary outcomes (1)
Disease progression
Incidence of complications and re-hospitalization at 48 weeks after discharge
Measured: 48 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start6 Jan 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2028 (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 Liver FailureStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingli He, Pro., Study director, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740696
- Sponsor's protocol ID
- XJTU1AF2023LSK-019
- Acronym
- RESOLVE-C
- Status last verified
- Jan 2023
- First submitted
- 8 Feb 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Zhang Q, Li J, Wu X, Zang Q, Wang Q, Huang P, Wang Y, Zhang S, Liu S, Zhu C, Zhao Y, Yan T, He Y. mNGS improves the efficiency of infection diagnosis and treatment in acute-on-chronic liver failure. BMC Gastroenterol. 2026 Jan 20;26(1):129. doi: 10.1186/s12876-025-04601-8.
PubMed 41559596
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry Study for Optimal Management of Liver Failure in the Chinese Population (RESOLVE-C)
- ClinicalTrials.gov ID
- NCT05740696
- Acronym / sponsor ID
- RESOLVE-C / XJTU1AF2023LSK-019
- Conditions
- Liver Failure
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 6 Jan 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 23 Feb 2023 (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.
Liver failure is the most severe form of liver damage caused by viral, alcoholic, drug-related and ischemia-reperfusion factors, often combined with extrahepatic organ damage, resulting in a high mortality rate. This study intends to construct a real-world case registry database of inpatients with liver failure based on an electronic clinical data collection system through a multicenter collaborative network to study the clinical characteristics, epidemiology of bacterial and fungal infections, the impact of sarcopenia on clinical prognosis, and optimization of treatment strategies such as antiviral and artificial liver in Chinese inpatients with liver failure. The cohort and experience generated from this study will be used as a support for a series of future studies to focus on clinical issues such as infection, end-stage liver disease combined with organ failure, and early warning of critically ill patients.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALF | – | Procedure: ALFacute liver failure |
| SALF | – | Procedure: SALFsubacute liver failure |
| ACLF | – | Procedure: ACLFacute-on-chronic liver failure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receive guideline-based systemic therapy. The follow-up assessments will be performed at week 1, 2, 3, 4, 12, 24 and 48 or any time if there is a change in condition. All the patients receive routine biochemical tests and imaging examinations.
Key inclusion criteria (4 listed)
- Extreme weakness with significant gastrointestinal symptoms such as anorexia, vomiting and abdominal distention;
- Elevated alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) with progressive jaundice (TBil≥85.5 μmol/L);
- Bleeding tendency with PTA ≤ 60% or INR ≥ 1.5.
Key exclusion criteria (1 listed)
- An event or complication that, in the judgment of the investigator, significantly affects the assessment of clinical status.
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 |
|---|---|---|
| ALFAcute onset, no history of underlying liver disease, liver failure characterized by degree Ⅱ or above hepatic encephalopathy developed within 2 weeks | Procedure or surgery | ALF |
| SALFThe onset was acute, with no history of underlying liver disease, and clinical manifestations of liver failure appeared between 2 and 26 weeks | Procedure or surgery | SALF |
| ACLFOn the basis of chronic liver disease, the clinical manifestations of acute liver decompensation and liver failure appear in a short period | Procedure or surgery | ACLF |
Primary outcome
Overall survival
Time frame: 28-day
28-day survival rates without liver transplantation
Overall survival
Time frame: 90-day
90-day survival rates without liver transplantation
1 secondary outcome
Disease progression
Time frame: 48 weeks after discharge
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Derived from this study: PubMed 41559596Liu Y, Zhang Q, Li J, Wu X, Zang Q, Wang Q, Huang P, Wang Y, Zhang S, Liu S, Zhu C, Zhao Y, Yan T, He Y. mNGS improves the efficiency of infection diagnosis and treatment in acute-on-chronic liver failure. BMC Gastroenterol. 2026 Jan 20;26(1):129. doi: 10.1186/s12876-025-04601-8.
Related trials for 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
Longitudinal Study of Ultra-rare Inherited Metabolic and Degenerative Neurological Diseases.
Inherited Disease, Rare Diseases
Active, not recruiting
LiverPAL: A Trial of Inpatient Palliative Care for Patients With Advanced Liver Disease
Liver Disease Chronic, End Stage Liver DIsease
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
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.
Yingli He, Pro. study director
First Affiliated Hospital Xi'an Jiaotong University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Failure, run by First Affiliated Hospital Xi'an Jiaotong University at 14 sites in China.
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 4 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yingli He, Pro. (0086-18991232863, heyingli2000@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 28-day). 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 NCT05740696, 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 Feb 2023.