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

Terminated

• Conditions: Liver Cirrhoses
• Interventions: Other: Trans-thoracic ultrasound

• Registration Number: NCT03650660
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-30
• Study First Submitted: 2018-08-27
• Study First Submitted QC: 2018-08-27
• Study First Posted: 2018-08-29
• Primary Completion: 2020-02-21
• Study Completion: 2020-06-26
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-03
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with liver cirrhosis	Trans-thoracic ultrasound	-

Primary Outcome Measures

Name	Time	Method
Concordance in Left Ventricular Ejection Fraction measurement on trans-thoracic ultrasound by expert versus a non-specialist gastroenterologist with standard training	48 hours	Difference in measured Left Ventricular Ejection Fraction (%)
Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training	48 hours	Difference in measured velocity-time integral (cm)
Concordance in E' wave at the lateral mitral ring and mitral E wave measurement by expert versus a non-specialist gastroenterologist with standard training	48 hours	Difference in measured E / E' ratio

Secondary Outcome Measures

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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nimes, France