Informations générales (source: ClinicalTrials.gov)
Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of Cirrhosis. (EmiC)
Observational
Hospices Civils de Lyon (Voir sur ClinicalTrials)
juin 2019
juin 2025
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier de la Croix Rousse - 69004 - Lyon - France | Fanny Lebossé, PhD | Contact (sur clinicalTrials) | |||
Critères
Tous
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)
- 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)
- 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)