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

Liver Cirrhoses Clinical Trial

— EchoCirrho  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03650660
• Other study ID #: Local/2017/JFB-01
• Status: Terminated
• Start date: March 30, 2018
• Est. completion date: June 26, 2020

Study information

• Verified date: August 2020
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: June 26, 2020
• Est. primary completion date: February 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Ascites
• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

Other:
• Trans-thoracic ultrasound
Trans-thoracic ultrasound performed by an expert and a non-expert

Locations

Country	Name	City	State
France	CHU Nimes	Nimes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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