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

C.Surgical Procedure; Cardiac Clinical Trial

— EMOA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02571920
• Other study ID #: A14-D64-VOL.23
• Status: Completed
• Phase: N/A
• First received: October 6, 2015
• Last updated: November 28, 2017
• Start date: November 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2017
• Source: University Hospital, Caen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3099
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• C.Surgical Procedure; Cardiac

Locations

Country	Name	City	State
France	Caen University Hospital	Caen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Caen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the incidence of norepinephrine use		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the incidence of dobutamine use		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the incidence of epinephrine use		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the length of norepinephrine infusion		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the length of dobutamine infusion		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of cardiac output monitoring and the length of epinephrine infusion		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery		Up to 28 days after surgery (length of intensive care unit stay)
Secondary	Correlation between use of of cardiac output monitoring and the incidence of postoperative complications		Up to 28 days after surgery (length of intensive care unit stay)