Clinical trial NCT03650660: 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
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Liver Cirrhoses
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training
timeFrame: 48 hours
measure: Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training
timeFrame: 48 hours
measure: Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training
timeFrame: 48 hours
Secondary outcomes:
measure: Death rate
timeFrame: Day 28
measure: Duration of hospitalization
timeFrame: End of follow-up (maximum 28 days)
measure: Number of admissions to intensive care
timeFrame: End of follow-up (maximum 28 days)
measure: Consummation of diuretics
timeFrame: Day 0
measure: albumin infusion necessity
timeFrame: Day 0
measure: Use of vasopressors
timeFrame: Day 0
measure: auto ejection fraction measurement on trans-thoracic ultrasound by expert
timeFrame: Day 0
measure: lateral mitral annulus measurement on trans-thoracic ultrasound by expert
timeFrame: Day 0
measure: Mitral E wave measurement on trans-thoracic ultrasound by expert
timeFrame: Day 0
measure: Mitral A wave measurement on trans-thoracic ultrasound by expert
timeFrame: Day 0
measure: Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert
timeFrame: Day 0
measure: Presence of intrapulmonary shunt
timeFrame: Day 0
measure: Presence of aortic stenosis
timeFrame: Day 0
measure: Presence of mitral insufficiency
timeFrame: Day 0
measure: Presence of mitral stenosis
timeFrame: Day 0
measure: left atrium surface area
timeFrame: Day 0
measure: left ventricle diameter
timeFrame: Day 0
measure: Septal wall thickness
timeFrame: Day 0
measure: Posterior wall thickness
timeFrame: Day 0
measure: tricuspid annular plane systolic excursion
timeFrame: Day 0
measure: tricuspid annular plane systolic velocity
timeFrame: Day 0
measure: heart chamber dilation
timeFrame: Day 0
measure: pulmonary arterial hypertension
timeFrame: Day 0
measure: Pericardial effusion
timeFrame: Day 0
Other outcomes:
Locations:
city: Nimes
country: France
facility: CHU Nimes
Study officials:
affiliation: CHU Nimes
name: Jean François Bourgaux
role: PRINCIPAL_INVESTIGATOR
References: