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NCT Number: NCT03905746

Study of microRNAs in a Decompensated Cirrhosis

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.

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Key information

Conditions

Cirrhosis Acute Decompensation Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier de la Croix Rousse

Lyon, 69004, France

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

blood sample at Day 0

Other

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

Other

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

Other

stool sample (2mL) will be performed at D0 (inclusion), at the time of routine exams.

Primary outcomes

  1. Plasma levels of 800 miRNA between the 2 subgroups of the AD group according to the retrospective diagnosis of sepsis or not

    Time frame: Day 0

    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.

Secondary outcomes

  1. miRNA profiles

    Time frame: Day 0

    Difference between miRNA profiles identified in a subgroup of patients with secondary infection during admission (DA group) and a subgroup of patients who did not developing a secondary infection on admission

  2. miRNA profiles

    Time frame: Day 2

    Difference between miRNA profiles identified in a subgroup of patients with secondary infection during admission (DA group) and a subgroup of patients who did not developing a secondary infection on admission

  3. miRNA profiles

    Time frame: Day 7

    Difference between miRNA profiles identified in a subgroup of patients with secondary infection during admission (DA group) and a subgroup of patients who did not developing a secondary infection on admission

  4. miRNA profiles

    Time frame: Day 0

    Difference in miRNA profiles identified in a subgroup of patients with secondary infection 6 months, 1 year and 6 years after inclusion (DA group) and a subgroup of patients developing no secondary infection during follow-up (DA group).

  5. miRNA profiles

    Time frame: Day 2

    Difference in miRNA profiles identified in a subgroup of patients with secondary infection 6 months, 1 year and 6 years after inclusion (DA group) and a subgroup of patients developing no secondary infection during follow-up (DA group).

  6. miRNA profiles

    Time frame: Day 7

    Difference in miRNA profiles identified in a subgroup of patients with secondary infection 6 months, 1 year and 6 years after inclusion (DA group) and a subgroup of patients developing no secondary infection during follow-up (DA group).

  7. Correlation between plasma levels of 800 miRNAs and degree of portal hypertension

    Time frame: Day 0

  8. Correlation between plasma levels of 800 miRNAs and nutritional profile (Liver Frailty Index, bracchial circumference)

    Time frame: Day 0

  9. miRNA profiles

    Time frame: Day 0

    Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)

  10. miRNA profiles

    Time frame: Day 2

    Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)

  11. miRNA profiles

    Time frame: Day 7

    Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)

  12. Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression

    Time frame: Day 0

  13. Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression

    Time frame: Day 2

  14. Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.

    Time frame: Day 0

    DA group and pathological control

  15. Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.

    Time frame: Day 2

    DA group

  16. Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.

    Time frame: Day 7

    DA group

  17. Difference in miRNA profiles between patients with a new episode of cirrhosis decompensation at 6 months, 1 year and 5 years from inclusion and surviving patients (DA group)

    Time frame: Day 0

    DA group

  18. Difference in miRNA profiles between patients with a new episode of cirrhosis decompensation at 6 months, 1 year and 5 years from inclusion and surviving patients (DA group)

    Time frame: Day 2

    DA group

  19. Difference in miRNA profiles between patients with a new episode of cirrhosis decompensation at 6 months, 1 year and 5 years from inclusion and surviving patients (DA group)

    Time frame: Day 7

    DA group

  20. Difference between miRNA profiles / subgroup of the pathological control group presenting a 1st episode of cirrhosis decompensation and in the subgroup presenting no 1st episode of cirrhosis decompensation at 6 months, 1 and 5 years of inclusion

    Time frame: Day 0

    pathological control group

  21. Association between miRNA expression and PBMC phenotype in the different groups (DA and pathological controls) and subgroups

    Time frame: Day 0

    control group and DA group / Subgroups :DA group: infection or not, secondary infection or not, evolutionary profile; pathological control group: decompensation at 6 Months, 1 and 5 years or not

  22. Association between miRNA expression and PBMC phenotype in subgroups (DA group: infection or not, secondary infection or not, evolutionary profile at 6 Months, 1 year and 5 years or not)

    Time frame: Day 2

    DA group

  23. Association between miRNA expression and PBMC phenotype in subgroups (DA group: infection or not, secondary infection or not, evolutionary profile at 6 Months, 1 year and 5 years or not)

    Time frame: Day 7

    DA group

  24. Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)

    Time frame: Day 0

    pathological control group and DA group ; determined by spectral cytometry on the one hand, and single cell RNA sequencing and single cell secretome analysis on the other.

  25. Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)

    Time frame: Day 2

    DA group ; determined by spectral cytometry on the one hand, and single cell RNA sequencing and single cell secretome analysis on the other.

  26. Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)

    Time frame: Day 7

    DA group ; determined by spectral cytometry on the one hand, and single cell RNA sequencing and single cell secretome analysis on the other.

  27. Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.

    Time frame: Day 0

    control group and DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.

  28. Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.

    Time frame: Day 2

    DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.

  29. Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.

    Time frame: Day 7

    DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.

  30. Correlation between i) the proportion of T and B cells circulating subpopulations and ii) circulating levels of potential biomarkers (concentrations of cytokines in plasma, concentration of circulating bacterial DNA).

    Time frame: Day 0

    control group and DA group

  31. Correlation between i) the proportion of T and B cells circulating subpopulations and ii) circulating levels of potential biomarkers (concentrations of cytokines in plasma, concentration of circulating bacterial DNA).

    Time frame: Day 2

    DA group

  32. Correlation between i) the proportion of T and B cells circulating subpopulations and ii) circulating levels of potential biomarkers (concentrations of cytokines in plasma, concentration of circulating bacterial DNA).

    Time frame: Day 7

    DA group

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EmiC

Important dates

Study start
2019
Primary completion
2033
Study completion
2034
First posted
Apr 5, 2019
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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