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

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

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.

Study Overview

• Status: Completed
• Conditions: C.Surgical Procedure; Cardiac

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 3099

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Caen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving elective cardiac surgery during the study period

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Marc-Olivier Fischer, University Hospital, Caen; Principal Investigator: Fabien Dechanet, University Hospital, Caen; Principal Investigator: Raphaël D'Orlando, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 8, 2015

Study Record Updates

• Last Update Posted (Actual): November 30, 2017
• Last Update Submitted That Met QC Criteria: November 28, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiac output
• Other Study ID Numbers: A14-D64-VOL.23