NCT03905746: EmiC

Study of microRNAs in a Decompensated Cirrhosis

Recruiting now Last updated 18 June 2025

What this trial tests

trial testing blood sample at Day 0 in Cirrhosis in 444 participants. Currently enrolling.

Timeline

26 June 2019

Primary endpoint
26 December 2033

26 June 2034

Quick facts

Lead sponsor	Hospices Civils de Lyon
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	444
Start date	26 June 2019
Primary completion	26 December 2033
Estimated completion	26 June 2034
Sites	1 location across France

Drugs / interventions tested

• blood sample at Day 0
• blood sample at Day 2 and Day 7
• stool sample at Day 0

Conditions studied

• Cirrhosis — all drugs for Cirrhosis →
• Acute Decompensation — all drugs for Acute Decompensation →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Cirrhosis or Acute Decompensation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Update in Epigenetics in Metabolic-Associated Fatty Liver Disease.
   Rodríguez-Sanabria JS, Escutia-Gutiérrez R, Rosas-Campos R, Armendáriz-Borunda JS, et al · · 2021 · cited 24× · PMID 35087844 · DOI 10.3389/fmed.2021.770504
2. Circulating microRNAs improve bacterial infection diagnosis and overall survival prediction in acute decompensation of liver cirrhosis.
   Chouik Y, Lebossé F, Plissonnier ML, Lega JC, et al · · 2023 · cited 3× · PMID 37575179 · DOI 10.1016/j.isci.2023.107427
3. Confident Structural Annotation of Bile Acid Isomers Combining Electron-Activated Dissociation or Ion Mobility with High-Resolution Mass Spectrometry in Metabolomics
   Brunet T, De Boni R, Massias J, Rodrigues L, et al ·