NCT02407873

Brief Summary

The score on the Edmonton frail scale will be recorded in 250 consecutive patient aged of 75 years or more and undergoing elective cardiac surgery. In those patients the investigators will also record the ITU length of stay, the hospital length of stay, the incidence of complications, the ability to be discharged home and to live independently at postoperative day 30. The ability of the Edmonton score to predict complication, prolonged hospital and ITU length of stay as well as loss of autonomy at discharge and day 30 will be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration 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

January 8, 2014

Completed
24 days until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
1.2 years until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

October 18, 2017

Status Verified

October 1, 2015

Enrollment Period

3.3 years

First QC Date

January 8, 2014

Last Update Submit

October 17, 2017

Conditions

Keywords

aged of 75 years or more

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality

    30 Days

Secondary Outcomes (4)

  • Loss of autonomy at discharge (Edmonton score)

    30 Days

  • Loss of autonomy at day 30 (Edmonton score)

    30 days

  • Incidence of predefined complications

    30 Days

  • Length of hospital stay

    30 days

Study Arms (1)

Cardiac surgery

Other: Non

Interventions

NonOTHER
Cardiac surgery

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient aged 75 year and over undergoing elective cardiac surgery

You may qualify if:

  • yo and older
  • Elective cardiac surgery

You may not qualify if:

  • Refuse or inability to give consent
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU of Liege

Liège, 4000, Belgium

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Anaesthesia and Intensive Care Medicine

Study Record Dates

First Submitted

January 8, 2014

First Posted

April 3, 2015

Study Start

February 1, 2014

Primary Completion

June 1, 2017

Study Completion

August 1, 2017

Last Updated

October 18, 2017

Record last verified: 2015-10

Locations