FrailtyNCT02669927
Frailty and Postoperative Shock
An observational study of Frailty and Elderly, run by Université Catholique de Louvain.
Trial summary
To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery. Read more about this study
- Who is it for?
- Ages 45 years and older
- What is being tested?
- Observational
- How many people
- 53 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 53 patients (age = 82 ans [56-98]) hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015
Who may be able to join
- hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015
Who cannot join
- non-traumatic hip fracture
- refusal
About this study
To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.
- Being tested
- Observational
- Keywords
- hip surgery, frail older people
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationalOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2013
- Primary completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Forget Patrice, Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669927
- Sponsor's protocol ID
- 2012/17DEC/539
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty and Postoperative Shock
- ClinicalTrials.gov ID
- NCT02669927
- Acronym / sponsor ID
- 2012/17DEC/539
- Keywords
- hip surgery, frail older people
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jan 2016 (actual)
- First posted
- 1 Feb 2016 (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.
To find an objective, affordable and manageable way to measure frailty in elderly patients and to examine relationship between peri-operative metabolism of frail older people and outcome after hip surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 53 patients (age = 82 ans [56-98]) hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015
Key inclusion criteria (1 listed)
- hospitalized in St-Luc Hospital (Belgium) for hip surgery between 2013 and 2015
Key exclusion criteria (2 listed)
- non-traumatic hip fracture
- refusal
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 |
|---|---|---|
| Observational | Other | – |
Primary outcome
Mortality
Time frame: up to one year
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 1 Feb 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Elderly, run by Université Catholique de Louvain.
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 1 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 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Mortality (time frame: up to one year). 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 1 Feb 2016.