Study of microRNAs in a Decompensated Cirrhosis

Cirrhosis Clinical Trial

— EmiC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03905746
• Other study ID #: 69HCL19_0020
• Secondary ID: 2019-A00266-51
• Status: Recruiting
• Start date: June 26, 2019
• Est. completion date: June 26, 2025

Study information

• Verified date: January 2023
• Source: Hospices Civils de Lyon
• Contact: Fanny Lebossé, PhD
• Phone: 04 26 10 93 39
• Email: Fanny.lebosse[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: June 26, 2025
• Est. primary completion date: December 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Decompensation
• Cirrhosis
• Fibrosis
• Liver Cirrhosis

Intervention

Other:
• blood sample at Day 0
40mL blood (plasma and PBMCs) will be performed at D0 (inclusion), at the time of routine exams. (20 ml will be used for study analyzes ; 20mL will constitute the biological collection)
• blood sample at Day 2 and Day 7
20mL blood (plasma and PBMCs) will be performed at Day 2 and Day 7 from recruitment, at the time of routine exams. These two samples will constitute the biological collection.
• stool sample at Day 0
stool sample (2mL) will be performed at D0 (inclusion), at the time of routine exams.

Locations

Country	Name	City	State
France	Centre Hospitalier de la Croix Rousse	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma levels of 800 miRNA between the 2 subgroups of the AD group according to the retrospective diagnosis of sepsis or not	The difference of miRNAs levels will assess in patients recruited in the AD group who will be retrospectively diagnosed as septic at the time of enrollment and compare them non septic patients.	Day 0