Veno-arterial Extracorporeal Membrane Oxygenation Prior to Left Ventricular Assist Device Implantation. (LVAD-ECMO)
Veno-arterial Extracorporeal Membrane Oxygenation Support Prior to Left Ventricular Assist Device Implantation : Initial Patients Characteristics and 6 Month Follow-up, a Retrospective Study (2013-2017) (LVAD-ECMO)
Cardiogenic shock is an uncommun pathology with a high mortatily rate around 45%. Veno arterial extracorporeal membrane oxygenation (VA-ECMO) is a temporary extracorporeal assist device which restore an adequate blood flow when a circulatory failure occures. VA-ECMO main indication is refractory cardiogenic shock whatever the etiology. Current medical care of terminal cardiac failure includes use of long-term mechanical circulatory support devices (MCSD) such as Left Ventricular Assist Device (LVAD). LVAD therapy may lead to heart transplant (bridge to transplantation), to recovery (bridge to recovery) or to permanent implantation (destination therapy). Few patients with refractory cardiogenic shock treated with VA-ECMO may secondarily need a long term MCSD with LVAD.
LVAD long-term heart assist showed interesting survival rate when implantation occured (71% after 2 years follow-up and 45% after 4 years follow-up) out of acute heart failure situation. There are only few datas concerning LVAD implantion during refractory cardiogenic shock, with a mortality between 20 to 50% in different studies.
In this way, in comparaison of current few datas on the subject of LVAD implantation under VA-ECMO, the investigators (15 french-speacking centers) would retrospectively describe a large population.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Nancy, Frankrike, 54000
- Rekruttering
- CHRU NANCY
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Ta kontakt med:
- Caroline FRITZ, MD
- Telefonnummer: +33383157379
- E-post: c.fritz@chru-nancy.fr
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Ta kontakt med:
- Bruno LEVY, MD-PhD
- Telefonnummer: +33383154469
- E-post: b.levy@chru-nancy.fr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Veno-arterial ExtraCorporeal Membrane Oxygenation prior to left ventricular assist device implantation.
- Veno-arterial ExtraCorporeal Membrane Oxygenation at the left ventricular assist device implantation operative time
Exclusion Criteria:
- ExtraCorporeal Membrane Oxygenation weaving before left ventricular assist device implantation.
- Cardiac assist devices other than Veno-arterial ExtraCorporeal Membrane Oxygenation
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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6-month hospital discharge after LVAD implantation
Tidsramme: 6 month after LVAD implantation
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6-month hospital discharge after LVAD implantation
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6 month after LVAD implantation
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Mortality rate
Tidsramme: up to six month after LVAD implantation
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Six month mortality rate after LVAD implantation
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up to six month after LVAD implantation
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ICU discharge
Tidsramme: up to six month after LVAD implantation
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Days until ICU discharge after LVAD implantation
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up to six month after LVAD implantation
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Quality of life
Tidsramme: up to six month after LVAD implantation
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ADL and IADL scale
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up to six month after LVAD implantation
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Hemodynamic Failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Amount of Norepinephrine infused
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Before LVAD implantation - up to 28 day - up to 6 month
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Cardiogenic failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Amount of inotrope infused
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Before LVAD implantation - up to 28 day - up to 6 month
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Cardio-circulatory failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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ECLS assistance
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Before LVAD implantation - up to 28 day - up to 6 month
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Renal failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Worst KDIGO stage
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Before LVAD implantation - up to 28 day - up to 6 month
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Hepatic failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Worst values of PT/bilirubin/ AST and ALT
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Before LVAD implantation - up to 28 day - up to 6 month
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Thrombosis complication
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Thrombosis event
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Before LVAD implantation - up to 28 day - up to 6 month
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Haemorragic complication
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Haemorragic event
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Before LVAD implantation - up to 28 day - up to 6 month
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Respiratory failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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Ventilation assistance
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Before LVAD implantation - up to 28 day - up to 6 month
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Neurological failure
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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neurological sequelae
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Before LVAD implantation - up to 28 day - up to 6 month
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Infection complication
Tidsramme: Before LVAD implantation - up to 28 day - up to 6 month
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documented infection
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Before LVAD implantation - up to 28 day - up to 6 month
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Bruno Levy, MD-PhD, CHRU NANCY
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PSS2017/LVADECMO-FRITZ/YB
Legemiddel- og utstyrsinformasjon, studiedokumenter
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