Clinical study on the organ correlation in acute liver diseases

JRCT ID: jRCT1030230206

Registered date:05/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Liver diseases
• Date of first enrollment: 02/06/2023
• Target sample size: 50
• Study type: Observational

Outcome(s)

• Primary Outcome: The frequency of cardiomyopathy, pulmonary hypertension, hepatopulmonary syndrome, and hepatorenal syndrome in ACLF and acute liver failure will be investigated, as well as their causes, risk factors and biomarkers for their development, and their subsequent clinical course.

Secondary Outcome

a. To examine the relationship between liver reserve test values (blood biochemistry, Child-Pugh score, MELD score, liver elasticity) and cardiac function factors, pulmonary hypertension factors, hepatopulmonary syndrome factors, and hepatorenal syndrome factors.
b. To examine the association between portal vein hemodynamic severity (hepatic venous pressure gradient, Doppler blood flow factors of portal vein and short circuit) and cardiac function factors, pulmonary hypertension factors, hepatopulmonary syndrome factors, and hepatorenal syndrome factors.
c. To examine changes in cardiac function factors, pulmonary hypertension factors, hepatopulmonary syndrome factors, and hepatorenal syndrome factors and their factors after 3 months.
d. To examine the association between prognosis and cardiac function factors, pulmonary hypertension factors, hepatopulmonary syndrome factors, and hepatorenal syndrome factors.
e. Examine differences in markers of cell death, endothelin, and cytokines and their potential as biomarkers depending on the site of angiography. In addition, we will examine whether markers of cell death, endothelin, and cytokines in urinalysis are biomarkers for prognosis, cardiac function, pulmonary hypertension, hepatopulmonary syndrome, and hepatorenal syndrome.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(1) Patients with liver disease who were admitted due to some exacerbating factor (liver failure, infection, hemorrhage, encephalopathy, ascites, dehydration, electrolyte abnormalities, etc.)
(2) Patients aged 18 years or older
(iii) Patients who have received a full explanation of the disease condition and treatment methods, have received an explanation of the study, and have obtained the free and voluntary written consent of the patient or a surrogate after full understanding of the study.

• Exclude criteria: Patients deemed unsuitable as subjects by the study investigator or sub-investigator

Related Information

• Primary Sponsor: Kato Naoya