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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02571920
Other study ID # A14-D64-VOL.23
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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