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 (EchoCirrho)

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 Overview

• Status: Terminated
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Other: Trans-thoracic ultrasound

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• France
  • Nimes, France, 30029
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

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.

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with liver cirrhosis	Other: Trans-thoracic ultrasound; Trans-thoracic ultrasound performed by an expert and a non-expert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 (%)	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	48 hours
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training	Difference in measured velocity-time integral (cm)	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death rate		Day 28
Duration of hospitalization		End of follow-up (maximum 28 days)
Number of admissions to intensive care		End of follow-up (maximum 28 days)
Consummation of diuretics		Day 0
albumin infusion necessity		Day 0
Use of vasopressors		Day 0
auto ejection fraction measurement on trans-thoracic ultrasound by expert	Doppler	Day 0
lateral mitral annulus measurement on trans-thoracic ultrasound by expert	Doppler	Day 0
Mitral E wave measurement on trans-thoracic ultrasound by expert	Doppler	Day 0
Mitral A wave measurement on trans-thoracic ultrasound by expert	Doppler	Day 0
Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert	Doppler	Day 0
Presence of intrapulmonary shunt	Y/N	Day 0
Presence of aortic stenosis	Y/N	Day 0
Presence of mitral insufficiency	Y/N	Day 0
Presence of mitral stenosis	Y/N	Day 0
left atrium surface area	cm2	Day 0
left ventricle diameter	mm	Day 0
Septal wall thickness	mm	Day 0
Posterior wall thickness	mm	Day 0
tricuspid annular plane systolic excursion	mm	Day 0
tricuspid annular plane systolic velocity	cm/s	Day 0
heart chamber dilation		Day 0
pulmonary arterial hypertension	mmHg	Day 0
Pericardial effusion		Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Jean François Bourgaux, Chu Nimes

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2018
• Primary Completion (Actual): February 21, 2020
• Study Completion (Actual): June 26, 2020

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis; Ascites
• Other Study ID Numbers: Local/2017/JFB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No