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

28. november 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

3099

Kontakter og lokationer

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

Studiesteder

  • Frankrig
      • Caen, Frankrig
        • CAEN University Hospital

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Hvad måler undersøgelsen?

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)

Samarbejdspartnere og efterforskere

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

Sponsor

University Hospital, Caen

Efterforskere

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

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)

1. november 2015

Primær færdiggørelse (Faktiske)

1. december 2015

Studieafslutning (Faktiske)

1. januar 2016

Datoer for studieregistrering

Først indsendt

6. oktober 2015

Først indsendt, der opfyldte QC-kriterier

7. oktober 2015

Først opslået (Skøn)

8. oktober 2015

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. november 2017

Sidst verificeret

1. november 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • A14-D64-VOL.23

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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