Investigating microRNAs in patients with decompensated cirrhosis

Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of Cirrhosis.

This study is testing if certain tiny molecules in blood and stool can help doctors spot early signs of infection in patients with severe liver disease.

Quick facts

• Study type: Observational
• Enrollment: 444 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hospices Civils de Lyon (other)
• Locations: 1 site (Lyon)
• Trial ID: NCT03905746 on ClinicalTrials.gov

What this trial studies

This observational study focuses on patients with cirrhosis who are experiencing acute decompensation, a critical condition that increases their risk of sepsis. The study aims to collect blood and stool samples to explore the role of microRNAs as potential diagnostic markers for early detection of sepsis in these patients. By identifying new tools for diagnosis, the study seeks to improve the management and treatment outcomes for cirrhotic patients facing septic complications. The research is being conducted at the Centre Hospitalier de la Croix Rousse in Lyon.

Who should consider this trial

Good fit: Ideal candidates for this study are patients with cirrhosis who are admitted within 48 hours for an episode of acute decompensation.

Not a fit: Patients with cirrhosis who are not experiencing acute decompensation or those who refuse participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early diagnosis and management of sepsis in cirrhotic patients, potentially reducing mortality rates.

How similar studies have performed: While the use of microRNAs in diagnostics is a growing field, this specific approach in the context of cirrhosis and sepsis is relatively novel and has not been extensively tested.

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)

Where this trial is running

Lyon

• Centre Hospitalier de la Croix Rousse — Lyon, France (RECRUITING)

Study contacts

• Study coordinator: Fanny Lebossé, PhD

Conditions: Cirrhosis, Acute Decompensation