NCT02571920

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,099

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
24 days until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

November 30, 2017

Status Verified

November 1, 2017

Enrollment Period

1 month

First QC Date

October 6, 2015

Last Update Submit

November 28, 2017

Conditions

C.Surgical Procedure; Cardiac

Keywords

cardiac surgerycardiac output

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 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)

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving elective cardiac surgery during the study period

You may qualify if:

  • 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
  • Pericardium surgical drainages
  • Sternal sepsis surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hospital

Caen, France

Location

Study Officials

  • Marc-Olivier Fischer

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Fabien Dechanet

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

  • Raphaël D'Orlando

    University Hospital, Caen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

January 1, 2016

Last Updated

November 30, 2017

Record last verified: 2017-11

Locations

FR(1)