Study of microRNAs in a Decompensated Cirrhosis

Launched by HOSPICES CIVILS DE LYON · Apr 4, 2019

Keywords

ClinConnect Summary

This clinical trial is exploring the use of tiny molecules called microRNAs to help diagnose and manage sepsis in patients with a serious liver condition known as cirrhosis. Cirrhosis can weaken the immune system, making patients more vulnerable to infections like sepsis, which can be life-threatening. The study aims to understand if measuring these microRNAs in the blood can provide new information to detect sepsis early, potentially improving treatment and reducing the need for unnecessary antibiotics.

To participate in this study, patients need to have cirrhosis and be admitted to the hospital within 48 hours of experiencing serious symptoms, such as jaundice (yellowing of the skin), confusion, or bleeding. The trial is currently recruiting participants, including those who are stable but have not been hospitalized in the past six months. If eligible, participants will have their blood tested for microRNAs, and the findings may help shape future treatments for cirrhosis patients at risk of sepsis. This research is essential because it aims to create better diagnostic tools and improve patient care in a situation where timing is critical for survival.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients with cirrhosis (determined either by histopathology or by association of clinical signs of portal hypertension and hepatocellular insufficiency and radiological signs (dysmorphic liver, evidences of portal hypertension (collateral circulation, ascites)).
• • AND
• • Not refusing his / her participation in the study after information (or non-opposition of the person of confidence if the patient has a disorder of consciousness or impaired judgment (hepatic encephalopathy) at the time of inclusion) AND
• * Admitted within 48 hours for an episode of acute decompensation (acute decompensation group = AD group), which is defined by the sudden occurrence of one or more of the following clinical or biological symptoms:
• • Jaundice
• • Hepatic encephalopathy
• • oedemato-ascitic decompensation
• • Gastro-intestinal bleeding
• • Acute renal failure (according to AKIN criteria (22)) and / or hyponatremia
• • Degradation of hepatocellular functions (decrease of prothrombin time and factor V measured in blood, increase of bilirubinemia) OR
• • Outpatient follow-up for stable cirrhosis, not admitted in the last 6 months for an episode of acute cirrhosis decompensation (pathological control group)
• Exclusion Criteria:
• • Minor or major patient under guardianship or curatorship
• • Pregnant women
• • Patient deprived of liberty
• • History of extra-digestive cancer
• • History of hepatocellular carcinoma or other hepatobiliary cancer
• • Chronic infection with Hepatitis B virus (defined by the presence of Antibodies to hepatitis B core antigen (anti-HBc) and the absence of Hepatitis B surface antibodies (anti-HBs)) identified by a recent serology (less than 6 months)
• • Chronic Hepatitis C Virus infection or cured for less than 6 months
• • Infection with the Human Immunodeficiency Virus identified by a recent serology (less than 6 months)