- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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)
Studie Overzicht
Toestand
Conditie
Gedetailleerde beschrijving
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
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
-
-
-
Caen, Frankrijk
- Caen University hospital
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Tijdsspanne: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Marc-Olivier Fischer, University Hospital, Caen
- Hoofdonderzoeker: Fabien Dechanet, University Hospital, Caen
- Hoofdonderzoeker: Raphaël D'Orlando, University Hospital, Caen
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- A14-D64-VOL.23
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .