EchoCirrho: 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

• Sponsor: Centre Hospitalier Universitaire de Nīmes (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03650660
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Actual Duration (Months): 26.9
• Patients Per Site Per Month: 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhoses	Other: Trans-thoracic ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 55 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Mar 30, 2018
• Actual Primary Completion Date: Feb 21, 2020
• Actual Study Completion Date: Jun 26, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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 (%)

2. 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

3. Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training [48 hours]

   Difference in measured velocity-time integral (cm)

Secondary Outcome Measures

1. Death rate [Day 28]

2. Duration of hospitalization [End of follow-up (maximum 28 days)]

3. Number of admissions to intensive care [End of follow-up (maximum 28 days)]

4. Consummation of diuretics [Day 0]

5. albumin infusion necessity [Day 0]

6. Use of vasopressors [Day 0]

7. auto ejection fraction measurement on trans-thoracic ultrasound by expert [Day 0]

   Doppler

8. lateral mitral annulus measurement on trans-thoracic ultrasound by expert [Day 0]

   Doppler

9. Mitral E wave measurement on trans-thoracic ultrasound by expert [Day 0]

   Doppler

10. Mitral A wave measurement on trans-thoracic ultrasound by expert [Day 0]

    Doppler

11. Inferior vena cava collapsibility index measurement on trans-thoracic ultrasound by expert [Day 0]

    Doppler

12. Presence of intrapulmonary shunt [Day 0]

    Y/N

13. Presence of aortic stenosis [Day 0]

    Y/N

14. Presence of mitral insufficiency [Day 0]

    Y/N

15. Presence of mitral stenosis [Day 0]

    Y/N

16. left atrium surface area [Day 0]

    cm2

17. left ventricle diameter [Day 0]

    mm

18. Septal wall thickness [Day 0]

    mm

19. Posterior wall thickness [Day 0]

    mm

20. tricuspid annular plane systolic excursion [Day 0]

    mm

21. tricuspid annular plane systolic velocity [Day 0]

    cm/s

22. heart chamber dilation [Day 0]

23. pulmonary arterial hypertension [Day 0]

    mmHg

24. Pericardial effusion [Day 0]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Nimes	Nimes		France	30029

Sponsors and Collaborators

• Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Jean François Bourgaux, CHU Nimes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03650660
• Other Study ID Numbers: Local/2017/JFB-01
• First Posted: Aug 29, 2018
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Cirrhosis; Fibrosis; Ascites

Study Results

No Results Posted as of Aug 5, 2020