Albumin Infusion in Inpatients With Decompensated Cirrhosis

NCT05719051 | Unknown FDA Drug

• 1 other identifier: RJH-Albumin
• Study Type: observational
• Target: 564
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Decompensated Cirrhosis; Acute-On-Chronic Liver Failure

Keywords

Albumin; decompensated cirrhosis; Systemic inflammation; Prognosis

Outcome Measures

Primary Outcomes (1)

• Transplant-free survival at day 28 since enrollment

  Transplant-free survival at day 28 since enrollment

  From enrollment (Day 1) to Day-28

Secondary Outcomes (6)

• Changes of inflammatory markers from baseline

  From baseline (sample collection date) to Day 7 and Day 14, respectively

• Cumulative incidence of nosocomial infection by day 28

  From enrollment (Day 1) to Day-28

• Cumulative incidence of SBP by day 28

  From enrollment (Day 1) to Day-28

• Cumulative incidence of AKI by day 28

  From enrollment (Day 1) to Day-28

• Cumulative incidence of ACLF by day 28

  From enrollment (Day 1) to Day-28

Study Arms (3)

High-dose group

Total Intravenous albumin infusion \>1.5g/kg per week while hospitalization

Drug: Albumin infusion

Medium-dose group

Total Intravenous albumin infusion 1.0 to 1.5g/kg per week while hospitalization

Drug: Albumin infusion

Low-dose group

Total Intravenous albumin infusion \<1.0g/kg per week while hospitalization

Drug: Albumin infusion

Interventions

Albumin infusion DRUG

Albumin infusion was administrated according to the standard clinical practice

High-dose group; Low-dose group; Medium-dose group

Eligibility Criteria

• Age: 16 Years - 80 Years
• Gender Eligibility Details: Based on the ID card
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• Patients with decompensated cirrhosis nonelective admitted for overt ascites, active gastrointestinal bleeding, hepatic encephalopathy, bacterial/fungal infection, or jaundice, etc.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Department of Infectious Diseases , Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Central Study Contacts

Qing Xie, M.D. Ph.D.

CONTACT

86-13651804273; xieqingrjh@163.com

Zhujun Cao, M.D. Ph.D.

CONTACT

15216652990; estherlucifer@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 8, 2023
• First Posted: February 8, 2023
• Study Start: February 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)