Investigating microRNAs in patients with decompensated cirrhosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Centre Hospitalier de la Croix Rousse
  Lyon, France Recruiting

Study contacts

• Study coordinator: Fanny Lebossé, PhD
• Email: Fanny.lebosse@chu-lyon.fr
• Phone: 04 26 10 93 39

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.