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

NCT03650660 | Terminated

• 2 other identifiers: Local/2017/JFB-012017-A03144-49
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (24)

• 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

Study Arms (1)

Patients with liver cirrhosis

Other: Trans-thoracic ultrasound

Interventions

Trans-thoracic ultrasound OTHER

Trans-thoracic ultrasound performed by an expert and a non-expert

Patients with liver cirrhosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

Related Publications (1)

• Prost A, Bourgaux JF, Louart B, Caillo L, Daurat A, Lefrant JY, Pouderoux P, Muller L, Roger C. Echocardiographic hemodynamic assessment in decompensated cirrhosis: comparison between Intensivists and Gastroenterologists. J Clin Monit Comput. 2023 Oct;37(5):1219-1228. doi: 10.1007/s10877-023-00983-w. Epub 2023 Feb 25.

  PMID: 36840793 RESULT

Study Officials

• Jean François Bourgaux

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2018
• First Posted: August 29, 2018
• Study Start: March 30, 2018
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: December 3, 2025

Record last verified: 2020-08

Locations

FR (1)