Frailty in Adult SurgeryNCT07452263
Modified Essential Frailty Toolset in Older Adults Undergoing Major Elective Surgery
An observational study of Frailty in Adult Surgery and Frailty Syndrome, run by University of Iceland at 1 site in Iceland.
Trial summary
Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool… Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgeries
- What is being tested?
- Major elective surgery
- Type of treatment
- Surgery or procedure
- How many people
- 250 participants
- Where
- 1 siteIceland
- Study dates
- 20 Jan 2025to 31 Dec 2026
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Older adult
Study population: he study population will consist of all patients ≥70 years who have present for preoperative assessment at the admissions department at Landspitali before undergoing major surgery, University Hospital of Iceland.
Who may be able to join
- Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.
- Patients assigned to undergo major surgery
Who cannot join
- Cardiac surgery
- Not undergoing planned surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iceland1 site, 1 recruiting
- Recruiting
Landspitali University hospital
Reykjavik, Hofudborgarsvaedid, 101
Luis Rabelo, 8203587, lgr2@hi.is
About this study
Official title: Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery
Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists.
The Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study.
Read more
We therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI <22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g/L for men and 120 g/L for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution.
This study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.
- Conditions
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgeries, Readmission Rates, Postoperative Complication
- Being tested
- Major elective surgery
- Keywords
- Frailty, Postoperative Outcomes, Major elective surgery, Surgical Frailty, Readmission, Complications
- Medical subject headings
- Frailty, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major elective surgeryProcedure or surgery
Any major elective surgery at Landspítali University Hospital
| Study group | Role | What they receive |
|---|---|---|
| Frailty screening cohort undergoing major elective surgery | Patients ≥ 70 years undergoing major elective surgery who are triaged to present for preoperative assessment at the admissions department at Landspitali University Hospital in Iceland. Patients who screen positive on the mEFT (≥3 points) will be considered frail. Those who do not screen positive (≤2 points) will be part of the control group (non-frail). Receives: Procedure: Major elective surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day Readmission
Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. Readmissions to the same hospital on the same day for the same principal diagnosis are not counted in the outcome.
Measured: From the day of surgery to postoperative day 90.
Surgical Complications
Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
Measured: From the same day after surgery to postoperative day 30.
Secondary outcomes (3)
Prolonged length of hospital stay
Prolonged length of hospital stay will be defined as an index hospitalization lasting 10 days or longer following the surgical procedure. Length of stay will be calculated as the number of days from the day of surgery to discharge.
Measured: Postoperative day 0 through discharge from the index hospitalization (up to 180 days).
180-day mortality
Defined as the death of the patient after surgery
Measured: Up to 180 days after the primary surgery
Non-home discharge
Non-home discharge will be identified as the postoperative hospital discharge to a nursing home or a rehabilitation center. Discharge to patient hotels will not be included. In addition, non-home discharge will not include patients who live in a nursing home prior to the surgery.
Measured: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start20 Jan 2025
- Primary completion31 May 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Frailty in Adult 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
- 250 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of Iceland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luis Gísli Rabelo, University of Iceland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452263
- Sponsor's protocol ID
- UI-Frailty-VRN25/2024
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
Publications
Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9.
PubMed 36307919
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modified Essential Frailty Toolset for Predicting Postoperative Complications and Readmission in Older Adults Undergoing Major Elective Surgery
- ClinicalTrials.gov ID
- NCT07452263
- Acronym / sponsor ID
- UI-Frailty-VRN25/2024
- Conditions
- Frailty in Adult Surgery, Frailty Syndrome, Elective Surgeries, Readmission Rates, Postoperative Complication
- Keywords
- Frailty, Postoperative Outcomes, Major elective surgery, Surgical Frailty, Readmission, Complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of IcelandUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Mar 2026 (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.
Frailty is a common geriatric syndrome associated with reduced physiological reserve and increased vulnerability to surgical stress. As the population ages, more older adults undergo major elective surgery, yet frailty is often insufficiently assessed in routine practice and no universally accepted screening tool exists.
The Essential Frailty Toolset (EFT) is a simple validated frailty assessments and has demonstrated strong predictive value for mortality and major postoperative complications, particularly in cardiac surgery populations. EFT incorporates four key domains of cognition, anemia, serum albumin, and physical function capturing both physical and cognitive vulnerability. A modified version (mEFT) has been developed to improve feasibility and applicability in broader surgical settings, requiring minimal training and only a few minutes to administer. Despite its promise, mEFT has not been evaluated in elderly patients undergoing major elective non-cardiac surgery, representing an important gap in the current literature and motivating the present study.
We therefore propose a modified and simplified frailty screening tool tailored for elderly patients undergoing major elective non-cardiac surgery at our institution. The modified Essential Frailty Toolset (mEFT) is a multi-dimensional assessment designed to address this gap by evaluating physical function, cognition, nutrition, and anemia in just a few minutes. In this version, the tool assigns points based on specific clinical markers: the Timed Up and Go (TUG) test provides one point for a time ≥11.0 seconds and two points for ≥15.0 seconds; the Clock Drawing Test (CDT) provides one point for a score of ≤2 on a 3-point scale; nutritional risk is captured with one point for a BMI <22.0 or unintentional weight loss of 5% over the last six months; and anemia provides one point based on hemoglobin levels (below 130g/L for men and 120 g/L for women). These modifications were made to enhance feasibility and clinical relevance in our population. Low serum albumin was rare in our cohort and therefore demonstrated limited discriminatory value as a screening marker. In contrast, low BMI and recent weight loss are well-established risk factors for malnutrition and sarcopenia and are readily obtainable in routine preoperative assessment. Similarly, both the TUG and CDT are quick, inexpensive, and require minimal training, making them well suited for large-scale screening in preoperative clinics.Importantly, the proposed components have been evaluated in a pilot study conducted in our institution.
This study will evaluate whether a high mEFT score (≥3) is associated with increased postoperative complications and 90-day readmissions among patients aged ≥70 years undergoing major elective surgery. Patients presenting for admission will be included. If mEFT accurately identifies high-risk patients, it may improve preoperative risk stratification, inform shared decision-making, and help identify individuals who could benefit from targeted prehabilitation, supporting broader implementation of frailty screening in surgical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Frailty screening cohort undergoing major elective surgery | – | Procedure: Major elective surgeryPatients ≥ 70 years undergoing major elective surgery who are triaged to present for preoperative assessment at the admissions department at Landspitali University Hospital in Iceland. Patients who screen positive on the mEFT (≥3 points) will be considered frail. Those who do not screen positive (≤2 points) will be part of the control group (non-frail). |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- he study population will consist of all patients ≥70 years who have present for preoperative assessment at the admissions department at Landspitali before undergoing major surgery, University Hospital of Iceland.
Key inclusion criteria (2 listed)
- Patients ≥ 70 years who present for preoperative work-up at the admissions department at Landspitali and undergo frailty screening.
- Patients assigned to undergo major surgery
Key exclusion criteria (2 listed)
- Cardiac surgery
- Not undergoing planned 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 |
|---|---|---|
| Major elective surgeryAny major elective surgery at Landspítali University Hospital | Procedure or surgery | Frailty screening cohort undergoing major elective surgery |
Primary outcome
90-day Readmission
Time frame: From the day of surgery to postoperative day 90.
Readmission to any hospital in Iceland where the patient is admitted to any inpatient department. Emergency department enrollment without admission will not be counted as readmission. Readmissions to the same hospital on the same day for the same principal diagnosis are not counted in the outcome.
Surgical Complications
Time frame: From the same day after surgery to postoperative day 30.
Description: This outcome measures the incidence of adverse events after surgery and will be categorized based on the Clavien-Dindo classification grading system using the cut-off of ≥2; complications requiring pharmacological intervention (grade II), requiring additional procedures (grade III), life-threatening complications(grade IV) and a complication resulting in death (grade V).
3 secondary outcomes
Prolonged length of hospital stay
Time frame: Postoperative day 0 through discharge from the index hospitalization (up to 180 days).
180-day mortality
Time frame: Up to 180 days after the primary surgery
Non-home discharge
Time frame: From the day of surgery (postoperative day 0) until discharge to a non-home destination or discharge from the primary hospitalization, whichever occurs first, assessed up to 180 days postoperatively.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Background: PubMed 36307919Rabelo LG, Bjornsdottir A, Jonsdottir AB, Einarsson SG, Karason S, Sigurdsson MI. Frailty assessment tools and associated postoperative outcomes in older patients undergoing elective surgery: A prospective pilot study. Acta Anaesthesiol Scand. 2023 Feb;67(2):150-158. doi: 10.1111/aas.14162. Epub 2022 Nov 9.
- Individual participant dataSharing planned: No. The individual participant data collected during this study will not be shared due to confidentiality. Additionally, there is no formal plan for making these data publicly available at this time.
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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.
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 Frailty in Adult Surgery and Frailty Syndrome, run by University of Iceland at 1 site in Iceland.
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: looking for participants now, as of the sponsor's last update on 10 Mar 2026. 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 Iceland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin I Sigurdsson, MD, PhD (+354-824-8282, mingi@hi.is), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
90-day Readmission (time frame: From the day of surgery to postoperative day 90.). 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?
On the ClinicalTrials.gov record for NCT07452263, which also lists 1 linked publication.
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 10 Mar 2026.