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Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)

28. november 2017 oppdatert av: University Hospital, Caen

Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)

Describe the proportion of patients who underwent cardiac surgery in France and benefiting from a monitoring cardiac output, describe the use of positive inotropic and vasoactive agents for cardiac surgery patients operated (type of catecholamines, their duration), describe the fluid replacement and transfusions of first 24 hours, describe the incidence of postoperative complications in patients undergoing cardiac surgery.

Studieoversikt

Status

Fullført

Detaljert beskrivelse

The perioperative management in cardiac surgery patients has changed dramatically in the last fifteen years with the development of new cardiac output monitoring devices, the availability of new inotropic molecules, and a modern treatment for cardio-circulatory failure.

However, few studies report the possible changes in practice. The last French national survey was conducted in 2001. Since then, the literature is poor on the subject, and the impact of new approaches has been only marginally addressed. Recently, a German postal survey was conducted among cardiac surgery anesthesiologists, but on purely declarative elements and without patient data.

The investigators offer a type of national prospective observational study to evaluate professional practices, morbidity and mortality in cardiac surgical patients. This study must include all patients undergoing cardiac surgery at the participating centers during 7 weeks.

The main objective of this work is to assess the proportion of patients undergoing cardiac surgery receiving a cardiac output monitoring.

Secondary objectives are to describe the relationship between the use of cardiac output monitoring and the use of positive inotropic agents and vasoactive (type molecules, duration), volume expansion and transfusions the first 24 hours, and the incidence postoperative complications for patients undergoing cardiac surgery.

Studietype

Observasjonsmessig

Registrering (Faktiske)

3099

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Caen, Frankrike
        • Caen University hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Patients receiving elective cardiac surgery during the study period

Beskrivelse

Inclusion Criteria:

  • Patients over 18 years old undergoing cardiac surgery during the study period

Non-inclusion Criteria:

  • age under 18 years old
  • Extracorporeal life support and others cardiac assistance
  • congenital cardiac surgery
  • TAVI procedures
  • Pericardium surgical drainages
  • Sternal sepsis surgery

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: Kohort
  • Tidsperspektiver: Potensielle

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)

Sekundære resultatmål

Resultatmål
Tidsramme
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of cardiac output monitoring and the incidence of dobutamine use
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of cardiac output monitoring and the incidence of epinephrine use
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of cardiac output monitoring and the length of dobutamine infusion
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of cardiac output monitoring and the length of epinephrine infusion
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)
Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
Tidsramme: Up to 28 days after surgery (length of intensive care unit stay)
Up to 28 days after surgery (length of intensive care unit stay)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Marc-Olivier Fischer, University Hospital, Caen
  • Hovedetterforsker: Fabien Dechanet, University Hospital, Caen
  • Hovedetterforsker: Raphaël D'Orlando, University Hospital, Caen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2015

Primær fullføring (Faktiske)

1. desember 2015

Studiet fullført (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først innsendt

6. oktober 2015

Først innsendt som oppfylte QC-kriteriene

7. oktober 2015

Først lagt ut (Anslag)

8. oktober 2015

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

30. november 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. november 2017

Sist bekreftet

1. november 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • A14-D64-VOL.23

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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