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Completed

NCT Number: NCT02571920

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

Secondary outcomes

  1. Correlation between use of cardiac output monitoring and the incidence of norepinephrine use

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  2. Correlation between use of cardiac output monitoring and the incidence of dobutamine use

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  3. Correlation between use of cardiac output monitoring and the incidence of epinephrine use

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  4. Correlation between use of cardiac output monitoring and the length of norepinephrine infusion

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  5. Correlation between use of cardiac output monitoring and the length of dobutamine infusion

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  6. Correlation between use of cardiac output monitoring and the length of epinephrine infusion

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  7. Correlation between use of of cardiac output monitoring and the incidence of red blood cell transfusion

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  8. Correlation between use of of cardiac output monitoring and the volume of fluid expansion during first day following cardiac surgery

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

  9. Correlation between use of of cardiac output monitoring and the incidence of postoperative complications

    Time frame: Up to 28 days after surgery (length of intensive care unit stay)

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Official study title

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

Acronym: EMOA

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Oct 8, 2015
Registry last updated
Nov 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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