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- Essai clinique 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)
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Caen, France
- Caen University hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
|---|---|
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Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Délai: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
Mesures de résultats secondaires
Mesure des résultats |
Délai |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Délai: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the incidence of dobutamine use
Délai: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the incidence of epinephrine use
Délai: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of cardiac output monitoring and the length of norepinephrine infusion
Délai: 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
Délai: 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
Délai: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion
Délai: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
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Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery
Délai: Up to 28 days after surgery (length of intensive care unit stay)
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Up to 28 days after surgery (length of intensive care unit stay)
|
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Correlation between use of of cardiac output monitoring and the incidence of postoperative complications
Délai: Up to 28 days after surgery (length of intensive care unit stay)
|
Up to 28 days after surgery (length of intensive care unit stay)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Marc-Olivier Fischer, University Hospital, Caen
- Chercheur principal: Fabien Dechanet, University Hospital, Caen
- Chercheur principal: Raphaël D'Orlando, University Hospital, Caen
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- A14-D64-VOL.23
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