C.Surgical Procedure; CardiacEMOANCT02571920
Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA)
An observational study of C.Surgical Procedure; Cardiac, run by University Hospital, Caen at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Cardiac
- How many people
- 3,099 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2015to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving elective cardiac surgery during the study period
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- cardiac surgery, cardiac output
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients undergoing cardiac surgery and receiving a cardiac output monitoring.
Measured: Up to 28 days after surgery (length of intensive care unit stay)
Secondary outcomes (9)
Correlation between use of cardiac output monitoring and the incidence of norepinephrine use
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 28 days after surgery (length of intensive care unit stay)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; CardiacStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Olivier Fischer, Principal investigator, University Hospital, CaenFabien Dechanet, Principal investigator, University Hospital, CaenRaphaël D'Orlando, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571920
- Sponsor's protocol ID
- A14-D64-VOL.23
- Acronym
- EMOA
- Status last verified
- Nov 2017
- First submitted
- 6 Oct 2015
- Last updated
- 30 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Monitoring, Positive Inotropic and Vasoactive Drugs During Cardiac Surgery (EMOA Study)
- ClinicalTrials.gov ID
- NCT02571920
- Acronym / sponsor ID
- EMOA / A14-D64-VOL.23
- Conditions
- C.Surgical Procedure; Cardiac
- Keywords
- cardiac surgery, cardiac output
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,099 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving elective cardiac surgery during the study period
Key inclusion criteria (8 listed)
- Patients over 18 years old undergoing cardiac surgery during the study period
- age under 18 years old
- Extracorporeal life support and others cardiac assistance
- congenital cardiac surgery
- TAVI procedures
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
9 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
Related trials for C.Surgical Procedure; Cardiac
Active, not recruiting
Acute Normovolemic Hemodilution in High Risk Cardiac Surgery Patients.
C.Surgical Procedure; Cardiac
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc-Olivier Fischer principal investigator
University Hospital, Caen
Fabien Dechanet principal investigator
University Hospital, Caen
Raphaël D'Orlando principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C.Surgical Procedure; Cardiac, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.