Prognostic Impact of Frailty Assessed by Edmondon in Elde... | NCT02407873

Studies
Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery

NCT02407873

Sponsor

University of Liege

Status

Completed

Last Update Posted

Oct 18, 2017Actual

Enrollment

254Actual

Phase

Not provided

Conditions

Elective Cardiac Surgery

Interventions

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Aug 2017Actual

First Submitted Date

Jan 8, 2014

First Submission Date that Met QC Criteria

Apr 2, 2015

First Posted Date

Apr 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2017

Last Update Posted Date

Oct 18, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jean François Brichant, Professor of Anaesthesia and Intensive Care Medicine, University of LiegePrincipal Investigator

Lead Sponsor

University of LiegeOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

30 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

254Actual

Label	Type	Description	Intervention Names
Cardiac surgery			Other: Non

Name	Type	Description	Arm Group Labels	Other Names
Non	Other		Cardiac surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
30-day mortality		30 Days

Secondary Outcomes

Measure	Description	Time Frame
Loss of autonomy at discharge (Edmonton score)		30 Days
Loss of autonomy at day 30 (Edmonton score)		30 days
Incidence of predefined complications

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

75 yo and older
Elective cardiac surgery

Exclusion Criteria:

Refuse or inability to give consent
Emergency surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

75 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Patient aged 75 year and over undergoing elective cardiac surgery

Sampling Method

Non-Probability Sample