Liver CirrhosesEchoCirrhoNCT03650660
Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist
An observational study of Liver Cirrhoses, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Trans-thoracic ultrasound
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2018to 26 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Cirrhosis patients admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.
Who may be able to join
- Patient must be an adult at least 18 years old
- Patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria)
- Admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.
Who cannot join
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant or breastfeeding
- Patient already participated in the study
Show all 11Show fewer
- Patient with cirrhosis admitted for a different decompensation (active digestive hemorrhage or sepsis)
- Poorly echogenic patient
- Patient withdraws consent
- Patient with anasarca of cardiac origin
- Ultrasound diagnosis of a severe cardiac pathology requiring specialized treatment in intensive care or cardiology (severe cardiac insufficiency, acute pulmonary edema, endocarditis, severe valvulopathy, cardiac tamponade, intracardiac thrombus)
Trial locations and contacts
1 site in 1 country.
About this study
The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.
- Conditions
- Liver Cirrhoses
- Being tested
- Trans-thoracic ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-thoracic ultrasoundOther
Trans-thoracic ultrasound performed by an expert and a non-expert
| Study group | Role | What they receive |
|---|---|---|
| Patients with liver cirrhosis | Not described Receives: Other: Trans-thoracic ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training
Difference in measured Left Ventricular Ejection Fraction (%)
Measured: 48 hours
Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training
Difference in measured E / E' ratio
Measured: 48 hours
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training
Difference in measured velocity-time integral (cm)
Measured: 48 hours
Secondary outcomes (24)
Death rate
Measured: Day 28
Duration of hospitalization
Measured: End of follow-up (maximum 28 days)
Number of admissions to intensive care
Measured: End of follow-up (maximum 28 days)
Consummation of diuretics
Measured: Day 0
albumin infusion necessity
Measured: Day 0
Use of vasopressors
Measured: Day 0
auto ejection fraction measurement on trans-thoracic ultrasound by expert
Doppler
Measured: Day 0
lateral mitral annulus measurement on trans-thoracic ultrasound by expert
Doppler
Measured: Day 0
Mitral E wave measurement on trans-thoracic ultrasound by expert
Doppler
Measured: Day 0
Mitral A wave measurement on trans-thoracic ultrasound by expert
Doppler
Measured: Day 0
Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert
Doppler
Measured: Day 0
Presence of intrapulmonary shunt
Y/N
Measured: Day 0
Presence of aortic stenosis
Y/N
Measured: Day 0
Presence of mitral insufficiency
Y/N
Measured: Day 0
Presence of mitral stenosis
Y/N
Measured: Day 0
left atrium surface area
cm2
Measured: Day 0
left ventricle diameter
mm
Measured: Day 0
Septal wall thickness
mm
Measured: Day 0
Posterior wall thickness
mm
Measured: Day 0
tricuspid annular plane systolic excursion
mm
Measured: Day 0
tricuspid annular plane systolic velocity
cm/s
Measured: Day 0
heart chamber dilation
Measured: Day 0
pulmonary arterial hypertension
mmHg
Measured: Day 0
Pericardial effusion
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2018
- Study start30 Mar 2018
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Why it stopped: departure of the principal recruiter in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean François Bourgaux, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03650660
- Sponsor's protocol ID
- Local/2017/JFB-01
- Other IDs
- 2017-A03144-49
- Acronym
- EchoCirrho
- Status last verified
- Aug 2020
- First submitted
- 27 Aug 2018
- Last updated
- 3 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Prost A, Bourgaux JF, Louart B, Caillo L, Daurat A, Lefrant JY, Pouderoux P, Muller L, Roger C. Echocardiographic hemodynamic assessment in decompensated cirrhosis: comparison between Intensivists and Gastroenterologists. J Clin Monit Comput. 2023 Oct;37(5):1219-1228. doi: 10.1007/s10877-023-00983-w. Epub 2023 Feb 25.
PubMed 36840793
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concordance Between Echocardiographic Assessment Performed in the Initial Phase of Decompensated Cirrhosis With Edema and Ascites by an Expert Intensive Care Physician and a Non-expert Gastroenterologist
- ClinicalTrials.gov ID
- NCT03650660
- Acronym / sponsor ID
- EchoCirrho / Local/2017/JFB-01
- Conditions
- Liver Cirrhoses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: departure of the principal recruiter in the study
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 29 Aug 2018 (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.
The investigators hypothesize that trans-thoracic ultrasound performed by non-specialist gastroenterologists with a standard training by intensive care doctors will give equivalent results to those achieved by experts for a simple evaluation of hemodynamic status.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with liver cirrhosis | – | Other: Trans-thoracic ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cirrhosis patients admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.
Key inclusion criteria (3 listed)
- Patient must be an adult at least 18 years old
- Patient has known or suspected cirrhosis (diagnosed by biopsy or based on recognized clinical/biological/radiological criteria)
- Admitted to the gastroenterology service for odematous-ascitic decompensation defined by edema of the lower limbs, and/or ascites, anasarca, associated or not with weight gain.
Key exclusion criteria (11 listed)
- The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
- The subject refuses to sign the consent
- It is impossible to give the subject informed information
- The patient is under safeguard of justice or state guardianship
- Patient is pregnant or breastfeeding
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 |
|---|---|---|
| Trans-thoracic ultrasoundTrans-thoracic ultrasound performed by an expert and a non-expert | Other | Patients with liver cirrhosis |
Primary outcome
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training
Time frame: 48 hours
Difference in measured Left Ventricular Ejection Fraction (%)
Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training
Time frame: 48 hours
Difference in measured E / E' ratio
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training
Time frame: 48 hours
Difference in measured velocity-time integral (cm)
24 secondary outcomes
Death rate
Time frame: Day 28
Duration of hospitalization
Time frame: End of follow-up (maximum 28 days)
Number of admissions to intensive care
Time frame: End of follow-up (maximum 28 days)
Consummation of diuretics
Time frame: Day 0
albumin infusion necessity
Time frame: Day 0
Use of vasopressors
Time frame: Day 0
auto ejection fraction measurement on trans-thoracic ultrasound by expert
Time frame: Day 0
lateral mitral annulus measurement on trans-thoracic ultrasound by expert
Time frame: Day 0
Mitral E wave measurement on trans-thoracic ultrasound by expert
Time frame: Day 0
Mitral A wave measurement on trans-thoracic ultrasound by expert
Time frame: Day 0
Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert
Time frame: Day 0
Presence of intrapulmonary shunt
Time frame: Day 0
Presence of aortic stenosis
Time frame: Day 0
Presence of mitral insufficiency
Time frame: Day 0
Presence of mitral stenosis
Time frame: Day 0
left atrium surface area
Time frame: Day 0
left ventricle diameter
Time frame: Day 0
Septal wall thickness
Time frame: Day 0
Posterior wall thickness
Time frame: Day 0
tricuspid annular plane systolic excursion
Time frame: Day 0
tricuspid annular plane systolic velocity
Time frame: Day 0
heart chamber dilation
Time frame: Day 0
pulmonary arterial hypertension
Time frame: Day 0
Pericardial effusion
Time frame: Day 0
Results and safety
The study was stopped early (reason given: departure of the principal recruiter in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Results publication: PubMed 36840793Prost A, Bourgaux JF, Louart B, Caillo L, Daurat A, Lefrant JY, Pouderoux P, Muller L, Roger C. Echocardiographic hemodynamic assessment in decompensated cirrhosis: comparison between Intensivists and Gastroenterologists. J Clin Monit Comput. 2023 Oct;37(5):1219-1228. doi: 10.1007/s10877-023-00983-w. Epub 2023 Feb 25.
Related trials for Liver Cirrhoses
RecruitingPhase 4
Optimizing Portal Hypertension With TIPS and Interval Metabolic Surgery for Advanced Liver Disease
Liver Cirrhoses, Portal Hypertension Related to Cirrhosis
Not yet recruiting
The Application of Lifestyle Enhancing Validated Integrative Therapies for Everyday Pain in Cirrhosis
Cirrhoses, Liver
RecruitingPhase 4
Role of Allopurinol in Prevention of Complications Related to Decompensated Cirrhosis of Liver
Cirrhoses, Liver, Decompensated Cirrhosis of Liver
Not yet recruitingObservational study
Detecting Liver Fibrosis in Patients At-risk
Fatty Liver, NAFLD - Non-Alcoholic Fatty Liver Disease
Active, not recruitingObservational study
Appropriate Management of Hepatic EncePhalopaThy AmonG cirrhOtic patieNts Admitted to Internal Medicine
Cirrhoses, Liver, Portal Hypertension Related to Cirrhosis
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. This study is not recruiting at the moment.
Jean François Bourgaux principal investigator
CHU Nimes
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 Liver Cirrhoses, run by Centre Hospitalier Universitaire de Nīmes 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 3 Dec 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?
The study was stopped early (reason given: departure of the principal recruiter in the study). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training (time frame: 48 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03650660, which also lists 1 linked publication.
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 3 Dec 2025.