Actively Recruiting

Age: 18Years +
All Genders
NCT03905746

Study of microRNAs in a Decompensated Cirrhosis

Led by Hospices Civils de Lyon · Updated on 2025-06-18

444

Participants Needed

1

Research Sites

782 weeks

Total Duration

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AI-Summary

What this Trial Is About

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. 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.

CONDITIONS

Official Title

Study of microRNAs in a Decompensated Cirrhosis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with cirrhosis confirmed by pathology or clinical and radiological signs
  • Patients who agree to participate or whose representative consents if the patient has impaired judgment
  • Admission within 48 hours for an episode of acute decompensation defined by symptoms such as jaundice, hepatic encephalopathy, fluid buildup, gastrointestinal bleeding, acute kidney failure, or liver function decline
  • Outpatients with stable cirrhosis not admitted for acute decompensation in the past 6 months
Not Eligible

You will not qualify if you...

  • Minors or patients under guardianship or curatorship
  • Pregnant women
  • Patients deprived of liberty
  • History of extra-digestive cancer
  • History of hepatocellular carcinoma or other liver-related cancers
  • Chronic Hepatitis B infection identified by recent serology
  • Chronic or recently cured Hepatitis C infection (less than 6 months)
  • HIV infection identified by recent serology

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier de la Croix Rousse

Lyon, France, 69004

Actively Recruiting

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Research Team

F

Fanny Lebossé, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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