Acute-On-Chronic Liver FailureNCT05393453
Prognosis of Patients With Acute-on-chronic Liver Failure
An observational study of Acute-On-Chronic Liver Failure, run by Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute-On-Chronic Liver Failure
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Jun 2025
- Phase
- Observational
- 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 80 years
- All sexes
- Adult, Older adult
Study population: Patient with any cause of chronic liver disease who underwent acute liver dysfunction meets the criteria of ACLF of APASL.
Who may be able to join
- patients with evidence of chronic liver disease patients with liver failure
Who cannot join
- Patients who do not have chronic liver disease Patients who have hepatocellular carcinoma Patients who admitted for extrahepatic manifestations Patients who have HIV infection Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xiangya Hospital
Changsha, Hunan, 410000
Yan Huang, 13874854142, drhyan@163.com
About this study
Official title: The Investigate Outcomes and Prognostic Factors of Patients With Acute-on-chronic Liver Failure
Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the prognosis of patients with chronic liver disease related acute on-chronic liver failure in Central South China. No additional interventions other than routine treatment will be added.
Read the detailed description
Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the short-time and relatively long-term prognosis of patients with chronic liver disease related acute on-chronic liver failure. This is an observational study. All subjects will receive the currently recognized routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to blood routine, biochemistry, coagulation function, liver imaging, therapeutic drugs, etc. Complications and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.
- Conditions
- Acute-On-Chronic Liver Failure
- Medical subject headings
- Acute-On-Chronic Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with acute on chronic liver failure | All subjects will receive the currently routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination results of the subjects in the process of diagnosis and treatment, including but not limited to blood routine, biochemistry, coagulation function, liver imaging, therapeutic drugs, etc. Complications and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be collected after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-liver transplant mortality
short time mortality
Measured: 15 days
Non-liver transplant mortality
short time mortality
Measured: 30 days
Non-liver transplant mortality
short time mortality
Measured: 90 days
Non-liver transplant mortality
long time mortality
Measured: 12 months
Non-liver transplant mortality
long time mortality
Measured: 36 months
Secondary outcomes (6)
Liver transplantation rate
mortality of all patients including those receiving liver transplantation
Measured: 1 month
Liver transplantation rate
mortality of all patients including those receiving liver transplantation
Measured: 6 months
Liver transplantation rate
mortality of all patients including those receiving liver transplantation
Measured: 12 months
Model for disease severity
MELD score will be calculated and reported
Measured: 1 month
Model for disease severity
MELD score will be calculated and reported
Measured: 6 months
Model for disease severity
MELD score will be calculated and reported
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
- More trials run by Xiangya Hospital of Central South 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
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393453
- Sponsor's protocol ID
- Xiangya ACLF project
- Status last verified
- May 2022
- First submitted
- 14 May 2022
- Last updated
- 16 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigate Outcomes and Prognostic Factors of Patients With Acute-on-chronic Liver Failure
- ClinicalTrials.gov ID
- NCT05393453
- Acronym / sponsor ID
- Xiangya ACLF project
- Conditions
- Acute-On-Chronic Liver Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 26 May 2022 (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.
Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the prognosis of patients with chronic liver disease related acute on-chronic liver failure in Central South China. No additional interventions other than routine treatment will be added.
Detailed description
Patients with Acute on Chronic Liver Failure (ACLF) have high short-term mortality. The use of a severity score could define the patient's prognosis and would help determine in whom the treatment is effective. This study mainly prospectively analyze the clinical data of patients with chronic liver disease related acute liver failure admitted to the department of infectious diseases, Xiangya Hospital of Central South University, to analyze the short-time and relatively long-term prognosis of patients with chronic liver disease related acute on-chronic liver failure. This is an observational study. All subjects will receive the currently recognized routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to blood routine, biochemistry, coagulation function, liver imaging, therapeutic drugs, etc. Complications and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. All subjects will sign informed consent.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with acute on chronic liver failure | – | –All subjects will receive the currently routine treatment of liver failure and corresponding etiological treatment if needed. The researchers will collect various clinical examination results of the subjects in the process of diagnosis and treatment, including but not limited to blood routine, biochemistry, coagulation function, liver imaging, therapeutic drugs, etc. Complications and prognosis of patients will be recorded. Blood samples, urine and stool samples of all subjects will be collected after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with any cause of chronic liver disease who underwent acute liver dysfunction meets the criteria of ACLF of APASL.
Key inclusion criteria (1 listed)
- patients with evidence of chronic liver disease patients with liver failure
Key exclusion criteria (1 listed)
- Patients who do not have chronic liver disease Patients who have hepatocellular carcinoma Patients who admitted for extrahepatic manifestations Patients who have HIV infection Patients who admitted for symptomatic control of chronic liver disease, other than acute deterioration of liver function
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Non-liver transplant mortality
Time frame: 15 days
short time mortality
Non-liver transplant mortality
Time frame: 30 days
short time mortality
Non-liver transplant mortality
Time frame: 90 days
short time mortality
Non-liver transplant mortality
Time frame: 12 months
long time mortality
Non-liver transplant mortality
Time frame: 36 months
long time mortality
6 secondary outcomes
Liver transplantation rate
Time frame: 1 month
Liver transplantation rate
Time frame: 6 months
Liver transplantation rate
Time frame: 12 months
Model for disease severity
Time frame: 1 month
Model for disease severity
Time frame: 6 months
Model for disease severity
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Acute-On-Chronic Liver Failure
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Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
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CytOSorb TreatMent Of Critically Ill PatientS Registry
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A Novel Extracorporeal Liver Support Therapy In ALCF and to Evaluate the Efficacy of DIALIVE 2.0, a Liver Dialysis Device.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute-On-Chronic Liver Failure, run by Xiangya Hospital of Central South University at 1 site 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 1 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: status not confirmed, as of the sponsor's last update on 16 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Huang, Professor (13874854142, drhyan@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-liver transplant mortality (time frame: 15 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Jun 2022.