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Strain Analysis as a Right Ventricle Contractility Marker

30. oktober 2019 opdateret af: Hospices Civils de Lyon
The analysis of the systolic function (contractility) of the right ventricle (RV) is fundamental and central in many pathologies in intensive care unit. It can guide physicians in choosing therapeutics. The conventional ultrasound markers of RV function evaluation currently used are influenced by RV loading conditions, impairing their capacity to approximate a true contractility analysis. Myocardial strain imaging is a recent echographic technique that allows, among other things, to evaluate RV systolic function. It is a reproducible index with early variations which, if it proved to be independent pre-load, would help to better appreciate the RV contractility.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

16

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Frankrig
      • Lyon, Frankrig, 69004
        • Hôpital de la Croix Rousse
      • Lyon, Frankrig, 69007
        • Hôpital Saint Joseph Saint Luc

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Male or female ≥ 18 years
  • Patients with renal failure treated with intermittent hemodialysis
  • Patients who received an information and did not opposed to participate in the study, or, if unconscious patient at the time of inclusion: a person of trust as defined in Article L. 1111-6 of the Public Health Code, failing that, the family or, failing that, a person maintaining stable link, having received information and not opposed to participate in the study.

Exclusion Criteria:

  • Patients with heart disease (valvular, ischemic, rhythmic)
  • Patients with ejection fraction of left ventricular altered <45%
  • Chronic dialysis patients

  • Patients referred in Articles L. 1121-5, L.1121-6, L.1121-7, L.1121-8 of the Public Health Code:

    • Pregnant women, parturients or nursing mothers
    • Persons deprived of their liberty by a judicial or administrative decision, persons subject to psychiatric care, persons admitted to a health or social institution for purposes other than research
    • Minor Patients
    • Major persons who are subject to a legal protection measure or are unable to express their consent
  • Patients not willing to participate in the study
  • Patients not affiliated to a social security

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: ultrasound measurements
ultrasound measurements of myocardial deformation of free wall right ventricle during a sharp decline of right ventricle preload induced during a session of Intermittent hemodialysis.
Procedure: ultrasound measurements
ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the change in the Longitudinal strain of the free wall right ventricle
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Evaluation of the change in S' right ventricle wave
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in tricuspid annular plane systolic excursion (TAPSE)
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in visual left ventricular ejection fraction (LVEF)
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral E wave
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in mitral A wave
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in wave E ' at the lateral mitral ring
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Evaluation of the change in systolic fraction of pulmonary venous flow
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
measurements will be performed using an ultrasound device usually used in our center for the hemodynamic monitoring of patients in intensive care by transthoracic cardiac ultrasound
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
inter individual variability of Longitudinal strain of the free wall right ventricle
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Each measurement will be performed by two blind operators
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
intra individual variability of Longitudinal strain of the free wall right ventricle
Tidsramme: at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution
Each measurement will be performed by two blind operators
at baseline, 1 minute after starting hemodialysis, 1 hour after, and 5 minutes before restitution

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hospices Civils de Lyon

Efterforskere

  • Ledende efterforsker: Zoé Schmitt, Hôpital de la Croix-Rousse

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

25. november 2016

Primær færdiggørelse (Faktiske)

31. december 2017

Studieafslutning (Faktiske)

31. december 2017

Datoer for studieregistrering

Først indsendt

10. marts 2017

Først indsendt, der opfyldte QC-kriterier

20. marts 2017

Først opslået (Faktiske)

24. marts 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 69HCL16-0370

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