Elective Cardiac SurgeryNCT02407873
Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery
An observational study of Elective Cardiac Surgery, run by University of Liege at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Elective Cardiac Surgery
- What is being tested?
- Non
- How many people
- 254 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Aug 2017
- How long will I take part?
- 30 Days
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient aged 75 year and over undergoing elective cardiac surgery
Who may be able to join
- 75 yo and older
- Elective cardiac surgery
Who cannot join
- Refuse or inability to give consent
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Elective Cardiac Surgery
- Being tested
- Non
- Keywords
- aged of 75 years or more
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NonOther
| Study group | Role | What they receive |
|---|---|---|
| Cardiac surgery | Not described Receives: Other: Non |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
Measured: 30 Days
Secondary outcomes (4)
Loss of autonomy at discharge (Edmonton score)
Measured: 30 Days
Loss of autonomy at day 30 (Edmonton score)
Measured: 30 days
Incidence of predefined complications
Measured: 30 Days
Length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startFeb 2014
- Primary completionJun 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cardiac SurgeryStudies of the same condition, open and under way.
- 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
- 254 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean François Brichant, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02407873
- Sponsor's protocol ID
- 2013001
- Status last verified
- Oct 2015
- First submitted
- 8 Jan 2014
- Last updated
- 18 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Frailty Assessed by Edmondon in Elderly Patient Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02407873
- Acronym / sponsor ID
- 2013001
- Conditions
- Elective Cardiac Surgery
- Keywords
- aged of 75 years or more
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 3 Apr 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac surgery | – | Other: Non |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient aged 75 year and over undergoing elective cardiac surgery
Key inclusion criteria (2 listed)
- 75 yo and older
- Elective cardiac surgery
Key exclusion criteria (2 listed)
- Refuse or inability to give consent
- Emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non | Other | Cardiac surgery |
Primary outcome
30-day mortality
Time frame: 30 Days
4 secondary outcomes
Loss of autonomy at discharge (Edmonton score)
Time frame: 30 Days
Loss of autonomy at day 30 (Edmonton score)
Time frame: 30 days
Incidence of predefined complications
Time frame: 30 Days
Length of hospital stay
Time frame: 30 days
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 18 Oct 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Elective Cardiac Surgery, run by University of Liege at 1 site in Belgium.
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 2 inclusion and 2 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 18 Oct 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 Belgium. 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?
30-day mortality (time frame: 30 Days). 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 18 Oct 2017.