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Study of microRNAs in a Decompensated Cirrhosis

Key facts

Who runs it
Hospices Civils de Lyon
Where
France1 site in 1 countryChoose a country to see its sites
Trial code
Status
Recruiting
People taking part
444 people, planned
Started
26 Jun 2019
Expected to end
26 Jun 2034
Type of study
Observational, 2 groups
Treatments tested
  • blood sample at Day 0
  • blood sample at Day 2 and Day 7
  • stool sample at Day 0
Record updated
18 June 2025

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • 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)

Who cannot take part

  • 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)
  • Minor or major patient under guardianship or curatorship
  • Pregnant women
  • Patient deprived of liberty

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

Cirrhotic patients are at higher risk of sepsis due to impaired innate and adaptive immune responses. Septic complications represent a major issue in the management of cirrhotic patients, with a 1-month mortality rate of 23%, which increases to 80% at 3 months in case of associated organ failure.

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Delay to treatment initiation during a septic episode may increase the risk of complications and mortality of cirrhotic patients. However, the inappropriate use of antibiotics exposes cirrhotic patients to the risk of more severe infections due to multi-resistant organisms or fungi.

The use of diagnostic markers for sepsis is limited in the context of cirrhosis because of the lack of hepatic synthesis of these markers on the one hand and non-specific inflammation related to cirrhosis on the other hand.

Therefore, it is necessary to develop new tools for the early diagnosis of sepsis and appropriate management of cirrhotic patients.

The interest of microRNAs (miRNAs) in the diagnosis and prognosis of septic shock has been reported in the general population. No studies have described circulating miRNAs or reported their interest in the diagnosis of sepsis in a population of cirrhotic patients with acute decompensation (AD).

This preliminary study of 800 circulating miRNAs will be performed in a cohort of patients with acute cirrhosis decompensation, for whom the incidence of sepsis is estimated at 40%. The aim to evaluate the interest and feasibility of a larger study on the interest of circulating miRNAs in the early diagnosis of sepsis in cirrhotic patients. The long-term objective of this study is the development of biomarkers for the early management of cirrhotic patients with sepsis and the rationalization of antibiotic use to improve their prognosis.

The 2 groups in the trial

  • acute decompensation group

    patients admitted within 48 hours for acute decompensation of cirrhosis, with or without evidence of sepsis

    Treatment: blood sample at Day 0, blood sample at Day 2 and Day 7, and stool sample at Day 0

  • Pathological control group

    patients with Chronic Liver Disease (CLD), also named stable cirrhotic patients, without any admission in the last 6 months for an acute event

    Treatment: blood sample at Day 0 and stool sample at Day 0

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of Cirrhosis.
Record updated
18 June 2025