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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 (EchoCirrho)

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ClinicalTrials.gov Identifier: NCT03650660
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Liver Cirrhoses Other: Trans-thoracic ultrasound

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Study Type : Observational
Estimated Enrollment : 120 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 : March 30, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis Edema

Group/Cohort Intervention/treatment
Patients with liver cirrhosis Other: Trans-thoracic ultrasound
Trans-thoracic ultrasound performed by an expert and a non-expert




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 [ Time Frame: 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 [ Time Frame: 48 hours ]
    Difference in measured E / E' ratio

  3. Concordance in stroke volume measurement by expert versus a non-specialist gastroenterologist with standard training [ Time Frame: 48 hours ]
    Difference in measured velocity-time integral (cm)


Secondary Outcome Measures :
  1. Death rate [ Time Frame: Day 28 ]
  2. Duration of hospitalization [ Time Frame: End of follow-up (maximum 28 days) ]
  3. Number of admissions to intensive care [ Time Frame: End of follow-up (maximum 28 days) ]
  4. Consummation of diuretics [ Time Frame: Day 0 ]
  5. albumin infusion necessity [ Time Frame: Day 0 ]
  6. Use of vasopressors [ Time Frame: Day 0 ]
  7. auto ejection fraction measurement on trans-thoracic ultrasound by expert [ Time Frame: Day 0 ]
    Doppler

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

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

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

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

  12. Presence of intrapulmonary shunt [ Time Frame: Day 0 ]
    Y/N

  13. Presence of aortic stenosis [ Time Frame: Day 0 ]
    Y/N

  14. Presence of mitral insufficiency [ Time Frame: Day 0 ]
    Y/N

  15. Presence of mitral stenosis [ Time Frame: Day 0 ]
    Y/N

  16. left atrium surface area [ Time Frame: Day 0 ]
    cm2

  17. left ventricle diameter [ Time Frame: Day 0 ]
    mm

  18. Septal wall thickness [ Time Frame: Day 0 ]
    mm

  19. Posterior wall thickness [ Time Frame: Day 0 ]
    mm

  20. tricuspid annular plane systolic excursion [ Time Frame: Day 0 ]
    mm

  21. tricuspid annular plane systolic velocity [ Time Frame: Day 0 ]
    cm/s

  22. heart chamber dilation [ Time Frame: Day 0 ]
  23. pulmonary arterial hypertension [ Time Frame: Day 0 ]
    mmHg

  24. Pericardial effusion [ Time Frame: Day 0 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03650660


Contacts
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Contact: Jean François Bourgaux, MD 04.66.68.32.22 jean.francois.bourgaux@chu-nimes.fr

Locations
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France
CHU Nimes Recruiting
Nimes, France, 30029
Contact: Anissa Megzari    +33 (0)4.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: Jean François Bourgaux, MD         
Sub-Investigator: Adrien A Prost         
Sub-Investigator: Claire Roger, MD         
Sub-Investigator: Louart Benjamin, MD         
Sub-Investigator: Martin Mahul, MD         
Sub-Investigator: Aurélien Daurat, MD         
Sub-Investigator: Ludovic Caillo, MD         
Sub-Investigator: Bénédicte Brunaud-Gagniard, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: Jean François Bourgaux CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03650660     History of Changes
Other Study ID Numbers: Local/2017/JFB-01
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 29, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases