Decompensated CirrhosisNCT05719051
Albumin Infusion in Inpatients With Decompensated Cirrhosis
An observational study of Decompensated Cirrhosis and Acute-On-Chronic Liver Failure, run by Ruijin Hospital at 1 site in China.
Trial summary
Albumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Decompensated Cirrhosis, Acute-On-Chronic Liver Failure
- What is being tested?
- Albumin infusion
- Type of treatment
- Injection or infusion
- How many people
- 564 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2023to 31 Dec 2024
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Target population is hospitalized patients with decompensated cirrhosis. For the purpose of this study, two established prospect cohorts will be used retrospectively including the "RJH" cohort and the "SONIC" cohort. All patients in the abovementioned cohorts had at least one of the following events for inclusion: overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice.
Who may be able to join
- Patients with decompensated cirrhosis nonelective admitted for overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice, etc.
Who cannot join
- Age below 16 or over 80 years
- Lactation/ Pregnancy women
- HIV infection
- Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugular intrahepatic portosystemic shunting, liver biopsy) or reexamination or multidisciplinary consultation)
- Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies
- Previous liver transplantation
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- With previously known severe extra-hepatic diseases (e.g., chronic renal failure requiring hemodialysis, severe heart disease; severe chronic pulmonary disease, psychiatric disorders)
- Taking immunosuppressive or anticoagulation drugs for the treatment of extra-hepatic disease.
- Patient' s refusal to participation
- Failure to provide prior informed consent or with documented evidence that the patient has no legal surrogate decision maker and it appears unlikely that the patient will regain consciousness or sufficient ability to provide delayed informed consent
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: Effect of Albumin Infusion in Patients With Decompensated Cirrhosis Hospitalized for Treatment of Complications of Liver Disease
Albumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.
The purpose of this study is to compare the effects of different amount of human albumin infusion per week in patients with hospitalized decompensated cirrhosis on 28-day transplant-free survival and to further compare the alleviation of inflammation, reduction of incidence of nosocomial infection, spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), acute-on-chronic liver failure (ACLF), and 90-day transplant-free survival. This will be a multicenter, national, retrospective study. There will be no randomization in this retrospective study. All patients who meet the inclusion criteria and not the exclusion criteria will be enrolled. All identified patients who meet criteria will be given an ID number comprised of a site number and patient number.
Read the detailed description
Patients with decompensated cirrhosis frequently develop various complications, be it related to salt and water retention, renal dysfunction, hepatic encephalopathy, portal hypertensive bleeds, or various infections. These lead to frequent hospital admissions, impaired quality of life, and increased morbidities and mortality.
Although recent investigations have helped to elucidate the pathogenetic mechanisms that lead to the development of these complications, exactly how much each of these pathogenetic mechanisms contributes to the development of these complications is not clear. Among them, hypoalbuminemia has long been considered a cardinal feature of decompensated cirrhosis.
Human albumin is the main modulator of fluid distribution among the body compartments and also exerts many other biological properties unrelated to its oncotic power including antioxidation, immune modulation and anti-inflammatory effect, and endothelial stabilization as well as vascular integrity. Albumin infusion has been recommended by international guidelines after large-volume paracentesis in patients with ascites, or in spontaneous bacterial peritonitis to prevent and treat the hepatorenal syndrome. Long-term prophylactic administration of albumin to outpatients with prior history of ascites is also effective in preventing further complications and improving survival. A subsequent study suggests an anti-inflammatory effect of albumin in patients with cirrhosis; this finding suggests that infusions of albumin might increase survival by limiting systemic inflammation.
These promising data suggested a disease-modifying agent role of albumin in patients with decompensated cirrhosis. The investigators, therefore, hypothesized that albumin infusion in patients with hospitalized decompensated, even in short-term period use, could also improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.
To test these hypotheses, the investigators planned to perform retrospective analysis in two established cohorts of hospitalized decompensated cirrhosis: 1) the "RJH" cohort of decompensated cirrhosis in Ruijin Hospital enrolled between 2016 and 2018; 2) an established cohort of inpatients with cirrhosis enrolled from 23 centers in China between 2018 and 2019 (the "SONIC" study).
- Being tested
- Albumin infusion
- Keywords
- Albumin, decompensated cirrhosis, Systemic inflammation, Prognosis
- 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.
Albumin infusionDrug
Albumin infusion was administrated according to the standard clinical practice
| Study group | Role | What they receive |
|---|---|---|
| High-dose group | Total Intravenous albumin infusion >1.5g/kg per week while hospitalization Receives: Drug: Albumin infusion | |
| Medium-dose group | Total Intravenous albumin infusion 1.0 to 1.5g/kg per week while hospitalization Receives: Drug: Albumin infusion | |
| Low-dose group | Total Intravenous albumin infusion <1.0g/kg per week while hospitalization Receives: Drug: Albumin infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant-free survival at day 28 since enrollment
Transplant-free survival at day 28 since enrollment
Measured: From enrollment (Day 1) to Day-28
Secondary outcomes (6)
Changes of inflammatory markers from baseline
Changes of the level of each measured inflammatory marker (IL6, IL-8, TNF-a, etc.) at Day 7 and Day 14 as compared to the baseline level.
Measured: From baseline (sample collection date) to Day 7 and Day 14, respectively
Cumulative incidence of nosocomial infection by day 28
Cumulative incidence of nosocomial infection by day 28
Measured: From enrollment (Day 1) to Day-28
Cumulative incidence of SBP by day 28
Cumulative incidence of SBP by day 28
Measured: From enrollment (Day 1) to Day-28
Cumulative incidence of AKI by day 28
Cumulative incidence of AKI by day 28
Measured: From enrollment (Day 1) to Day-28
Cumulative incidence of ACLF by day 28
Cumulative incidence of ACLF by day 28
Measured: From enrollment (Day 1) to Day-28
Transplant-free survival at day 90 since enrollment
Transplant-free survival at day 90 since enrollment
Measured: From enrollment (Day 1) to Day-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Feb 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated CirrhosisStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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
- Retrospective
- Enrolment
- 564 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing XIe, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719051
- Sponsor's protocol ID
- RJH-Albumin
- Status last verified
- Jan 2023
- First submitted
- 8 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Albumin Infusion in Patients With Decompensated Cirrhosis Hospitalized for Treatment of Complications of Liver Disease
- ClinicalTrials.gov ID
- NCT05719051
- Acronym / sponsor ID
- RJH-Albumin
- Keywords
- Albumin, decompensated cirrhosis, Systemic inflammation, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 564 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Feb 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 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.
Albumin infusion in patients with hospitalized decompensated, even in short-term period use, could improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.
The purpose of this study is to compare the effects of different amount of human albumin infusion per week in patients with hospitalized decompensated cirrhosis on 28-day transplant-free survival and to further compare the alleviation of inflammation, reduction of incidence of nosocomial infection, spontaneous bacterial peritonitis (SBP), acute kidney injury (AKI), acute-on-chronic liver failure (ACLF), and 90-day transplant-free survival. This will be a multicenter, national, retrospective study. There will be no randomization in this retrospective study. All patients who meet the inclusion criteria and not the exclusion criteria will be enrolled. All identified patients who meet criteria will be given an ID number comprised of a site number and patient number.
Detailed description
Patients with decompensated cirrhosis frequently develop various complications, be it related to salt and water retention, renal dysfunction, hepatic encephalopathy, portal hypertensive bleeds, or various infections. These lead to frequent hospital admissions, impaired quality of life, and increased morbidities and mortality.
Although recent investigations have helped to elucidate the pathogenetic mechanisms that lead to the development of these complications, exactly how much each of these pathogenetic mechanisms contributes to the development of these complications is not clear. Among them, hypoalbuminemia has long been considered a cardinal feature of decompensated cirrhosis.
Human albumin is the main modulator of fluid distribution among the body compartments and also exerts many other biological properties unrelated to its oncotic power including antioxidation, immune modulation and anti-inflammatory effect, and endothelial stabilization as well as vascular integrity. Albumin infusion has been recommended by international guidelines after large-volume paracentesis in patients with ascites, or in spontaneous bacterial peritonitis to prevent and treat the hepatorenal syndrome. Long-term prophylactic administration of albumin to outpatients with prior history of ascites is also effective in preventing further complications and improving survival. A subsequent study suggests an anti-inflammatory effect of albumin in patients with cirrhosis; this finding suggests that infusions of albumin might increase survival by limiting systemic inflammation.
These promising data suggested a disease-modifying agent role of albumin in patients with decompensated cirrhosis. The investigators, therefore, hypothesized that albumin infusion in patients with hospitalized decompensated, even in short-term period use, could also improve survival through the reduction of systemic inflammation, which is the main driver of acute-on-chronic liver failure in cirrhosis. The effects could be highly associated with the albumin dosage. A comprehensive evaluation of the inflammation response by robust measurement is needed to prove insights into the therapeutic implications of albumin infusion.
To test these hypotheses, the investigators planned to perform retrospective analysis in two established cohorts of hospitalized decompensated cirrhosis: 1) the "RJH" cohort of decompensated cirrhosis in Ruijin Hospital enrolled between 2016 and 2018; 2) an established cohort of inpatients with cirrhosis enrolled from 23 centers in China between 2018 and 2019 (the "SONIC" study).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose group | – | Drug: Albumin infusionTotal Intravenous albumin infusion >1.5g/kg per week while hospitalization |
| Medium-dose group | – | Drug: Albumin infusionTotal Intravenous albumin infusion 1.0 to 1.5g/kg per week while hospitalization |
| Low-dose group | – | Drug: Albumin infusionTotal Intravenous albumin infusion <1.0g/kg per week while hospitalization |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Target population is hospitalized patients with decompensated cirrhosis. For the purpose of this study, two established prospect cohorts will be used retrospectively including the "RJH" cohort and the "SONIC" cohort. All patients in the abovementioned cohorts had at least one of the following events for inclusion: overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice.
Key inclusion criteria (1 listed)
- Patients with decompensated cirrhosis nonelective admitted for overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice, etc.
Key exclusion criteria (10 listed)
- Age below 16 or over 80 years
- Lactation/ Pregnancy women
- HIV infection
- Admitted for scheduled procedures (e.g., band ligation, splenectomy, transjugular intrahepatic portosystemic shunting, liver biopsy) or reexamination or multidisciplinary consultation)
- Hepatocellular carcinoma (HCC) outside Milan criteria or other disseminated malignancies
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 |
|---|---|---|
| Albumin infusionAlbumin infusion was administrated according to the standard clinical practice | Drug | High-dose group, Low-dose group, Medium-dose group |
Primary outcome
Transplant-free survival at day 28 since enrollment
Time frame: From enrollment (Day 1) to Day-28
Transplant-free survival at day 28 since enrollment
6 secondary outcomes
Changes of inflammatory markers from baseline
Time frame: From baseline (sample collection date) to Day 7 and Day 14, respectively
Cumulative incidence of nosocomial infection by day 28
Time frame: From enrollment (Day 1) to Day-28
Cumulative incidence of SBP by day 28
Time frame: From enrollment (Day 1) to Day-28
Cumulative incidence of AKI by day 28
Time frame: From enrollment (Day 1) to Day-28
Cumulative incidence of ACLF by day 28
Time frame: From enrollment (Day 1) to Day-28
Transplant-free survival at day 90 since enrollment
Time frame: From enrollment (Day 1) to Day-90
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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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 Decompensated Cirrhosis and Acute-On-Chronic Liver Failure, run by Ruijin Hospital 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 10 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 8 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 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 Qing Xie, M.D. Ph.D. (86-13651804273, xieqingrjh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant-free survival at day 28 since enrollment (time frame: From enrollment (Day 1) to Day-28). 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 8 Feb 2023.