CirrhosisEmiCNCT03905746
Study of microRNAs in a Decompensated Cirrhosis
An observational study of Cirrhosis and Acute Decompensation, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cirrhosis, Acute Decompensation
- What is being tested?
- blood sample at Day 0, blood sample at Day 2 and Day 7 and stool sample at Day 0
- How many people
- 444 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2019to 26 Jun 2034
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The patients concerned are cirrhotic patients, followed in the hepatology department of Pr Zoulim, in gastroenterology department of Dr Marielle Guillet and in intensive care unit of Dr Céline Guichon (Croix Rousse Hospital, North Hospital Group, Hospices Civils de Lyon), without a history of cancer or active infection with the virus of the hepatitis B, hepatitis C virus or HIV. 2 groups will be formed: * A group of cirrhotic patients with acute decompensation (AD group) * A group of stable cirrhotic patients (pathological controls)
Who may be able to join
- 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
Show all 11Show fewer
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier de la Croix Rousse
Lyon, 69004
Fanny Lebossé, PhD, 04 26 10 93 39 ext. +33, Fanny.lebosse@chu-lyon.fr
Fanny Lebossé, PhD
About this study
Official title: Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of 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.
Read more
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
- Cirrhosis, Acute Decompensation
- Being tested
- blood sample at Day 0, blood sample at Day 2 and Day 7, stool sample at Day 0
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample at Day 0Other
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 7Other
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 0Other
stool sample (2mL) will be performed at D0 (inclusion), at the time of routine exams.
| Study group | Role | What they receive |
|---|---|---|
| acute decompensation group | patients admitted within 48 hours for acute decompensation of cirrhosis, with or without evidence of sepsis Receives: Other: blood sample at Day 0; Other: blood sample at Day 2 and Day 7; Other: stool sample at Day 0 | |
| Pathological control group | patients with Chronic Liver Disease (CLD), also named stable cirrhotic patients, without any admission in the last 6 months for an acute event Receives: Other: blood sample at Day 0; Other: stool sample at Day 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 0
Secondary outcomes (32)
miRNA profiles
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
Measured: Day 0
miRNA profiles
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
Measured: Day 2
miRNA profiles
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
Measured: Day 7
miRNA profiles
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).
Measured: Day 0
miRNA profiles
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).
Measured: Day 2
miRNA profiles
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).
Measured: Day 7
Correlation between plasma levels of 800 miRNAs and degree of portal hypertension
Measured: Day 0
Correlation between plasma levels of 800 miRNAs and nutritional profile (Liver Frailty Index, bracchial circumference)
Measured: Day 0
miRNA profiles
Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)
Measured: Day 0
miRNA profiles
Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)
Measured: Day 2
miRNA profiles
Difference between miRNA profiles identified in different subgroups of patients in the DA group according to the mode progression (PREDICT study criteria)
Measured: Day 7
Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression
Measured: Day 0
Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression
Measured: Day 2
Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.
DA group and pathological control
Measured: Day 0
Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.
DA group
Measured: Day 2
Difference in miRNA profiles between patients who died without liver transplantation at 6 months, 1 year and 5 years from inclusion and surviving patients.
DA group
Measured: Day 7
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)
DA group
Measured: Day 0
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)
DA group
Measured: Day 2
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)
DA group
Measured: Day 7
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
pathological control group
Measured: Day 0
Association between miRNA expression and PBMC phenotype in the different groups (DA and pathological controls) and subgroups
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
Measured: Day 0
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)
DA group
Measured: Day 2
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)
DA group
Measured: Day 7
Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)
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.
Measured: Day 0
Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)
DA group ; determined by spectral cytometry on the one hand, and single cell RNA sequencing and single cell secretome analysis on the other.
Measured: Day 2
Phenotypic and functional profiles of T and B lymphocytes from patients with cirrhosis at different stages (pathological control group and DA group)
DA group ; determined by spectral cytometry on the one hand, and single cell RNA sequencing and single cell secretome analysis on the other.
Measured: Day 7
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
control group and DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.
Measured: Day 0
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.
Measured: Day 2
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
DA group ; Predictive value will be assessed by ROC curve ant AUC and then logistic regression will be performed.
Measured: Day 7
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).
control group and DA group
Measured: Day 0
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).
DA group
Measured: Day 2
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).
DA group
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2019
- Study start26 Jun 2019
- Primary completion26 Dec 2033 (estimated)
- Study completion26 Jun 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905746
- Sponsor's protocol ID
- 69HCL19_0020
- Other IDs
- 2019-A00266-51
- Acronym
- EmiC
- Status last verified
- Jun 2025
- First submitted
- 3 Apr 2019
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression and Variance of microRNAs in a Cohort of Patients With Acute Decompensation of Cirrhosis.
- ClinicalTrials.gov ID
- NCT03905746
- Acronym / sponsor ID
- EmiC / 69HCL19_0020
- Conditions
- Cirrhosis, Acute Decompensation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- 26 Dec 2033 (estimated)
- Study completion
- 26 Jun 2034 (estimated)
- First posted
- 5 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| acute decompensation group | – | Other: blood sample at Day 0, Other: blood sample at Day 2 and Day 7, Other: stool sample at Day 0patients admitted within 48 hours for acute decompensation of cirrhosis, with or without evidence of sepsis |
| Pathological control group | – | Other: blood sample at Day 0, Other: stool sample at Day 0patients with Chronic Liver Disease (CLD), also named stable cirrhotic patients, without any admission in the last 6 months for an acute event |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patients concerned are cirrhotic patients, followed in the hepatology department of Pr Zoulim, in gastroenterology department of Dr Marielle Guillet and in intensive care unit of Dr Céline Guichon (Croix Rousse Hospital, North Hospital Group, Hospices Civils de Lyon), without a history of cancer or active infection with the virus of the hepatitis B, hepatitis C virus or HIV. 2 groups will be formed: * A group of cirrhotic patients with acute decompensation (AD group) * A group of stable cirrhotic patients (pathological controls)
Key inclusion criteria (11 listed)
- 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:
- Outpatient follow-up for stable cirrhosis, not admitted in the last 6 months for an episode of acute cirrhosis decompensation (pathological control group)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample at Day 040mL 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) | Other | Pathological control group, acute decompensation group |
| blood sample at Day 2 and Day 720mL 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. | Other | acute decompensation group |
| stool sample at Day 0stool sample (2mL) will be performed at D0 (inclusion), at the time of routine exams. | Other | Pathological control group, acute decompensation group |
Primary outcome
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.
32 secondary outcomes
miRNA profiles
Time frame: Day 0
miRNA profiles
Time frame: Day 2
miRNA profiles
Time frame: Day 7
miRNA profiles
Time frame: Day 0
miRNA profiles
Time frame: Day 2
miRNA profiles
Time frame: Day 7
Correlation between plasma levels of 800 miRNAs and degree of portal hypertension
Time frame: Day 0
Correlation between plasma levels of 800 miRNAs and nutritional profile (Liver Frailty Index, bracchial circumference)
Time frame: Day 0
miRNA profiles
Time frame: Day 0
miRNA profiles
Time frame: Day 2
miRNA profiles
Time frame: Day 7
Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression
Time frame: Day 0
Correlation between monocyte expression of HLA-DR (mHLA-DR) and circulating miRNA expression
Time frame: Day 2
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
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
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
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
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
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
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
Association between miRNA expression and PBMC phenotype in the different groups (DA and pathological controls) and subgroups
Time frame: Day 0
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
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
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
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
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
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
Time frame: Day 0
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
Time frame: Day 2
Predictive value of miRNAs, ADM and cDPP3 for risk of secondary infection, further decompensation, death without liver transplantation.
Time frame: Day 7
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cirrhosis and Acute Decompensation, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fanny Lebossé, PhD (04 26 10 93 39 ext. +33, Fanny.lebosse@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2025.