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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

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

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03650660
Acronym
EchoCirrho
Enrollment
55
Registered
2018-08-29
Start date
2018-03-30
Completion date
2020-06-26
Last updated
2025-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhoses

Brief 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.

Interventions

OTHERTrans-thoracic ultrasound

Trans-thoracic ultrasound performed by an expert and a non-expert

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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 * 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)

Design outcomes

Primary

MeasureTime frameDescription
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training48 hoursDifference 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 training48 hoursDifference in measured E / E' ratio
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training48 hoursDifference in measured velocity-time integral (cm)

Secondary

MeasureTime frameDescription
Death rateDay 28
Duration of hospitalizationEnd of follow-up (maximum 28 days)
Number of admissions to intensive careEnd of follow-up (maximum 28 days)
Consummation of diureticsDay 0
albumin infusion necessityDay 0
Use of vasopressorsDay 0
auto ejection fraction measurement on trans-thoracic ultrasound by expertDay 0Doppler
lateral mitral annulus measurement on trans-thoracic ultrasound by expertDay 0Doppler
Mitral E wave measurement on trans-thoracic ultrasound by expertDay 0Doppler
Mitral A wave measurement on trans-thoracic ultrasound by expertDay 0Doppler
Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expertDay 0Doppler
Presence of intrapulmonary shuntDay 0Y/N
Presence of aortic stenosisDay 0Y/N
Presence of mitral insufficiencyDay 0Y/N
Presence of mitral stenosisDay 0Y/N
left atrium surface areaDay 0cm2
left ventricle diameterDay 0mm
Septal wall thicknessDay 0mm
Posterior wall thicknessDay 0mm
tricuspid annular plane systolic excursionDay 0mm
tricuspid annular plane systolic velocityDay 0cm/s
heart chamber dilationDay 0
pulmonary arterial hypertensionDay 0mmHg
Pericardial effusionDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026