- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02571920
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA) (EMOA)
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)
Studieoversikt
Status
Forhold
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
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Caen, Frankrike
- Caen University hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
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
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
Sponsor
Etterforskere
- Hovedetterforsker: Marc-Olivier Fischer, University Hospital, Caen
- Hovedetterforsker: Fabien Dechanet, University Hospital, Caen
- Hovedetterforsker: Raphaël D'Orlando, University Hospital, Caen
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
Andre studie-ID-numre
- A14-D64-VOL.23
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