Frail Elderly SyndromeFRACNCT04264351
Frailty, Anesthesia and Complications.
An observational study of Frail Elderly Syndrome and Anesthesia Complication, run by Fundacio Puigvert at 1 site in Spain.
Trial summary
Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frail Elderly Syndrome, Anesthesia Complication, Complication of Surgical Procedure
- How many people
- 413 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2017to Jan 2023
- How long will I take part?
- 1 Year
- 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 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing urological scheduled surgery in our centre, that fill in the inclusion criteria with no exclusion criteria.
Who may be able to join
- Patients who participate voluntarily
- Signed Informed consent
- 70+ years old
- Scheduled urological surgery with general or regional anesthesia and length of stay in hospital over 24 hours.
- Patients with preserved domiciliary deambulation without aid of another person. (walking sticks, or walkers are accepted)
Who cannot join
- No signing of the informed consent
- Surgery performed with local anesthetics
- Day surgery, extracorporeal wave lithotripsy or endourological catheterism
- Advanced diagnosed dementia
- Patients with chronic advanced disease or terminal oncological disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Frailty, Anesthesia and Complications in an Urological Setting.
Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.
Read the detailed description
Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.
Methods: prospective cohort study performed at Fundació Puigvert. Enrollment of 850 patients ≥70 y/o who undergo scheduled nephrourologic surgery. In the preoperative visit frailty is going to be evaluated using the Short Physical Performance Battery (SPPB), the Canadian Frailty Scale, the Mini-Cog test (Memory an executive functions), the Pfeiffer Test (Cognitive global screening), an involuntary loss of more than 4.5kg or 5% of weight in the previous year and physical activity using the Metabolic Equivalents of Task (MET). We will analyse the relation among frailty, medical, surgical postoperative complications and mortality at 30 days, 6 months and one year after the surgery.
The results will be adjusted by the possible confounding and interaction variables using a multivariate logistic regression model. The confounding /interaction variables will include demographic data, clinical and lab data and events arisen during the follow-up period.
- Conditions
- Frail Elderly Syndrome, Anesthesia Complication, Complication of Surgical Procedure, Postoperative Delirium, Physical Disability
- Keywords
- Frailty, Anesthesia, complications
- Medical subject headings
- Emergence Delirium, Frailty
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty as a risk factor of postoperative events.
Assessment the prevalence of frailty in the surgical settings defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems. Frailty is defined as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss
Measured: 2017-2021
Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery
Frailty is going to be evaluated in the anesthetic preoperative visit using the Short Physical Performance Battery (SPPB), Canadian Frailty Scale, Mini-Cog test (Memory an executive functions), Pfeiffer Test (Cognitive global screening), Involuntary loose of more than 4,5kg or 5% of weight in the previous year, physical activity using the Metabolic Equivalents of Task (MET).
Measured: 2017-2021
Secondary outcomes (3)
Postoperative events and frailty
Assessment of the association among frailty, medical and surgical postoperative complications at 30 days, 6 months and one year after the surgery.
Measured: 2017-2021
Mortality associated to frailty and its complications
Assessment of the association between frailty and mortality at 30 days, 6 months and one year after the surgery.
Measured: 2017-2021
Preoperative visit as a chance to assess frailty
Analyze which frailty evaluation tool works better in the preoperative visit setting.
Measured: 2017-2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Jan 2017
- Primary completionFeb 2021
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frail Elderly SyndromeStudies 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
- 413 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacio Puigvert
- Sponsor type
- University, hospital or other
- Collaborators
- Parc Sanitari Pere Virgili
- Responsible party
- Principal investigator, Merce Prieto Butillé, Fundacio Puigvert
- Investigators
- Sergi Sabate, MD PhD, Study director, Chair Anesthesiologist at Fundació Puigvert
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264351
- Sponsor's protocol ID
- FRAC1
- Acronym
- FRAC
- Status last verified
- Sep 2023
- First submitted
- 3 Jan 2019
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frailty, Anesthesia and Complications in an Urological Setting.
- ClinicalTrials.gov ID
- NCT04264351
- Acronym / sponsor ID
- FRAC / FRAC1
- Conditions
- Frail Elderly Syndrome, Anesthesia Complication, Complication of Surgical Procedure, Postoperative Delirium, Physical Disability
- Keywords
- Frailty, Anesthesia, complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 413 participants (actual)
- Lead sponsor
- Fundacio PuigvertUniversity, hospital or other
- Collaborators
- Parc Sanitari Pere Virgili
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- Feb 2021 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 11 Feb 2020 (actual)
- 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.
Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.
Detailed description
Objectives: To assess the prevalence of frailty in patients older than 70 y/o in nephrourologic surgery. To study if preoperative frailty is an independent predictor of immediate postoperative complications, after 30 days, 6 months and 1 year of follow-up. To detect if there are other independent risk factors for complications.
Methods: prospective cohort study performed at Fundació Puigvert. Enrollment of 850 patients ≥70 y/o who undergo scheduled nephrourologic surgery. In the preoperative visit frailty is going to be evaluated using the Short Physical Performance Battery (SPPB), the Canadian Frailty Scale, the Mini-Cog test (Memory an executive functions), the Pfeiffer Test (Cognitive global screening), an involuntary loss of more than 4.5kg or 5% of weight in the previous year and physical activity using the Metabolic Equivalents of Task (MET). We will analyse the relation among frailty, medical, surgical postoperative complications and mortality at 30 days, 6 months and one year after the surgery.
The results will be adjusted by the possible confounding and interaction variables using a multivariate logistic regression model. The confounding /interaction variables will include demographic data, clinical and lab data and events arisen during the follow-up period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing urological scheduled surgery in our centre, that fill in the inclusion criteria with no exclusion criteria.
Key inclusion criteria (5 listed)
- Patients who participate voluntarily
- Signed Informed consent
- 70+ years old
- Scheduled urological surgery with general or regional anesthesia and length of stay in hospital over 24 hours.
- Patients with preserved domiciliary deambulation without aid of another person. (walking sticks, or walkers are accepted)
Key exclusion criteria (5 listed)
- No signing of the informed consent
- Surgery performed with local anesthetics
- Day surgery, extracorporeal wave lithotripsy or endourological catheterism
- Advanced diagnosed dementia
- Patients with chronic advanced disease or terminal oncological disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frailty as a risk factor of postoperative events.
Time frame: 2017-2021
Assessment the prevalence of frailty in the surgical settings defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems. Frailty is defined as meeting three out of five phenotypic criteria indicating compromised energetics: low grip strength, low energy, slowed waking speed, low physical activity, and/or unintentional weight loss
Frailty will be evaluated during the preoperative visit of patients 70+ scheduled to uronephrologic surgery
Time frame: 2017-2021
Frailty is going to be evaluated in the anesthetic preoperative visit using the Short Physical Performance Battery (SPPB), Canadian Frailty Scale, Mini-Cog test (Memory an executive functions), Pfeiffer Test (Cognitive global screening), Involuntary loose of more than 4,5kg or 5% of weight in the previous year, physical activity using the Metabolic Equivalents of Task (MET).
3 secondary outcomes
Postoperative events and frailty
Time frame: 2017-2021
Mortality associated to frailty and its complications
Time frame: 2017-2021
Preoperative visit as a chance to assess frailty
Time frame: 2017-2021
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 Sep 2023.
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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.
Sergi Sabate, MD PhD study director
Chair Anesthesiologist at Fundació Puigvert
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 Frail Elderly Syndrome and Anesthesia Complication, run by Fundacio Puigvert at 1 site in Spain.
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 5 inclusion and 5 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 Sep 2023. 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 Spain. 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?
Frailty as a risk factor of postoperative events. (time frame: 2017-2021). The study lists 2 primary outcomes in all. 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 Sep 2023.