- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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)
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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Caen, Frankreich
- Caen University hospital
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Beobachtungsmodelle: Kohorte
- Zeitperspektiven: Interessent
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Zeitfenster: 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)
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
|
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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 dobutamine infusion
Zeitfenster: 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 length of epinephrine infusion
Zeitfenster: 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 red blood cell transfusion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Marc-Olivier Fischer, University Hospital, Caen
- Hauptermittler: Fabien Dechanet, University Hospital, Caen
- Hauptermittler: Raphaël D'Orlando, University Hospital, Caen
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- A14-D64-VOL.23
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