Clinical trial NCT06865898: Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology
Official title: Plasma Proteomics Study of End-Stage Liver Disease Patients Based on Olink Technology
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: HBV Related Acute-on-chronic Liver Failure
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2025-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with HBV related liver cirrhosis，HBV related acute-on-chronic hepatic dysfunction and HBV related acute-on-chronic liver failure

Brief summary: Exploring Early Biomarkers of Hepatitis B Virus-Related Acute-on-Chronic Liver Failure Using Olink Proteomics

Detailed description: The rationale for this study is that, with the changing epidemiology of liver diseases, traditional diagnostic methods are no longer sufficient to meet clinical needs. Olink technology, however, offers the potential to discover novel biomarkers. By comparing the plasma proteomic profiles of patients with cirrhosis and liver failure, we aim to identify clinically significant markers. This not only has the potential to enhance early diagnostic capabilities but also provides an important basis for personalized treatment.

Eligibility criteria: Inclusion Criteria:

* HBV-LC patients were diagnosed based on previous liver biopsy results or clinical evidence and laboratory tests of previous decompensation for more than three months, including ascites, gastrointestinal bleeding, infection, hepatic encephalopathy, or a combination of these symptoms, endoscopic examination (esophageal and gastric varices), and radiological imaging of portal hypertension and/or liver nodules.

The inclusion criteria for HBV-ACHD patients in this study were based on patients with chronic stable decompensated cirrhosis who experienced an acute decompensation within three months. The reference criteria for acute decompensation in the HBV-ACHD group were as follows: patients with previously diagnosed decompensated cirrhosis presenting with a high level of jaundice (total bilirubin ≥5 mg/dL) HBV-ACLF was categorized into three grades based on the severity of the condition. The inclusion criteria for HBV-ACLF-1 were as follows: patients presenting with liver failure alone with an international normalized ratio (INR) ≥1.5 and/or kidney dysfunction and/or hepatic encephalopathy (HE) grade I or II. HBV-ACLF-2 was defined by dual-organ system failure, while HBV-ACLF-3 was characterized by failure involving three or more organ systems.

Exclusion Criteria:

* Associated with other types of hepatitis virus infection or HIV infection, alcoholic liver disease, autoimmune liver disease, drug-induced liver injury; ② Suffering from primary liver cancer or severe heart, digestive, lung, kidney, neurological and psychiatric diseases; ③ Patients with incomplete data and patients unable to participate in the experiment.

Primary outcomes:
measure: Mortality
timeFrame: 28 days, 90 days
Secondary outcomes:
measure: Differential protein levels
timeFrame: 28 days, 90 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
References: