FrailtyAGEDUNCT05369962
Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound
An observational study of Frailty and Adverse Event, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Frailty, Adverse Event
- What is being tested?
- Ultrasound
- Type of treatment
- Medical device
- How many people
- 68 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 May 2022to 20 May 2023
- How long will I take part?
- 3 Months
- 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 >70 years and older presenting in the ED of the UMCG hospital who are participating in the Acutelines bio-databank are eligible for inclusion.
Who may be able to join
- Age (>70 years)
- Presenting to the ED of the UMCG for one of the following specialties: internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, gastrointestinal/liver medicine, or emergency medicine (non-trauma).
- Consent obtained for participation in the Acutelines bio-databank
Who cannot join
- Unable to obtain ultrasound image of rectus femoris (e.g. amputation, edema)
- Paresis or paralysis of one or both legs
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.
Read the detailed description
Background:
Older people visit the Emergency Department (ED) more frequently then younger people and have a higher risk of functional decline, ED revisit or death. Several screening tools (such as the Dutch safety management system (VMS) and Acutely Presenting Older Patient (APOP)) have been developed to identify patients at the highest risk of adverse outcomes. Almost all require adequate communication with the patient, which is not always possible, for example when elderly patients present with a delirium. Point of Care Ultrasonography (POCUS) may be a valuable alternative screening tool in these instances.
Main research question:
To identify whether POCUS measurement of the rectus femoris muscle cross-sectional area (Qcsa) can be used as an alternative screening tool to predict functional decline, ED revisit or death in elderly patients in the ED.
Design (including population, confounders/outcomes):
This is a single centre prospective trial. Patients >70 years and older presenting in the ED of the University Medical Centre Groningen (UMCG) who are participating in the Acutelines bio-databank are eligible for inclusion. 68 patients will be included. Data will be extracted from the Acutelines bio-databank. A trained physician will perform ultrasound measurements in a standardized way.
Expected results:
The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.
- Conditions
- Frailty, Adverse Event
- Being tested
- Ultrasound
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDevice
Ultrasound measurements of the Qcsa
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Qcsa
POCUS Qcsa in older patients in the ED.
Measured: 1 day of admission to ED
ED revisit
Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.
Measured: 3 months
Mortality
Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.
Measured: 3 months
Secondary outcomes (4)
ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score
To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.
Measured: 3 months
Mortality: Ultrasound Qcsa versus Karnofsky Performance Score
To compare the ability of the Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.
Measured: 3 months
ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score
To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict ED revisit in older patients in the ED.
Measured: 3 months
Mortality: Ultrasound Qcsa plus Karnofsky Performance Score
To compare the added value of Qcsa ultrasound versus the Karnofsky Performance Score (gold standard) to predict mortality in older patients in the ED.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start10 May 2022
- Primary completion18 Feb 2023
- Study completion20 May 2023
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 FrailtyStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- 68 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Svenja Lichelle Haak, University Medical Center Groningen
- Investigators
- Svenja Haak, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369962
- Sponsor's protocol ID
- 202100945
- Acronym
- AGEDU
- Status last verified
- Mar 2025
- First submitted
- 21 Mar 2022
- Last updated
- 27 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Haak SL, Giezen L, Blanca D, Bouma HR, Lameijer H, Ter Maaten JC, Ter Avest E. Point-of-Care Ultrasound-Based Assessment of Sarcopenia to Predict Revisits or Mortality in Older Adults at the Emergency Department: A Prospective Observational Study. Ann Geriatr Med Res. 2026 Mar;30(1):77-84. doi: 10.4235/agmr.25.0106. Epub 2025 Nov 3.
PubMed 41328618
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Event Prediction in Geriatric Patients in the ED With Ultrasound
- ClinicalTrials.gov ID
- NCT05369962
- Acronym / sponsor ID
- AGEDU / 202100945
- Conditions
- Frailty, Adverse Event
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 10 May 2022 (actual)
- Primary completion
- 18 Feb 2023 (actual)
- Study completion
- 20 May 2023 (actual)
- First posted
- 11 May 2022 (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.
The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.
Detailed description
Background:
Older people visit the Emergency Department (ED) more frequently then younger people and have a higher risk of functional decline, ED revisit or death. Several screening tools (such as the Dutch safety management system (VMS) and Acutely Presenting Older Patient (APOP)) have been developed to identify patients at the highest risk of adverse outcomes. Almost all require adequate communication with the patient, which is not always possible, for example when elderly patients present with a delirium. Point of Care Ultrasonography (POCUS) may be a valuable alternative screening tool in these instances.
Main research question:
To identify whether POCUS measurement of the rectus femoris muscle cross-sectional area (Qcsa) can be used as an alternative screening tool to predict functional decline, ED revisit or death in elderly patients in the ED.
Design (including population, confounders/outcomes):
This is a single centre prospective trial. Patients >70 years and older presenting in the ED of the University Medical Centre Groningen (UMCG) who are participating in the Acutelines bio-databank are eligible for inclusion. 68 patients will be included. Data will be extracted from the Acutelines bio-databank. A trained physician will perform ultrasound measurements in a standardized way.
Expected results:
The aim of this study is to evaluate whether ultrasound measurements of the Qcsa can be utilized to identify older patients who are at risk for functional decline, ED revisit or death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients >70 years and older presenting in the ED of the UMCG hospital who are participating in the Acutelines bio-databank are eligible for inclusion.
Key inclusion criteria (3 listed)
- Age (>70 years)
- Presenting to the ED of the UMCG for one of the following specialties: internal medicine, nephrology, geriatric medicine, oncology, hematology, lung medicine, gastrointestinal/liver medicine, or emergency medicine (non-trauma).
- Consent obtained for participation in the Acutelines bio-databank
Key exclusion criteria (2 listed)
- Unable to obtain ultrasound image of rectus femoris (e.g. amputation, edema)
- Paresis or paralysis of one or both legs
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 |
|---|---|---|
| UltrasoundUltrasound measurements of the Qcsa | Device | – |
Primary outcome
Ultrasound Qcsa
Time frame: 1 day of admission to ED
POCUS Qcsa in older patients in the ED.
ED revisit
Time frame: 3 months
Is there a relation between the performed POCUS Qcsa measurement at ED visit and ED revisit in older patients.
Mortality
Time frame: 3 months
Is there a relation between the performed POCUS Qcsa measurement at ED visit and mortality in older patients.
4 secondary outcomes
ED revisit: Ultrasound Qcsa versus Karnofsky Performance Score
Time frame: 3 months
Mortality: Ultrasound Qcsa versus Karnofsky Performance Score
Time frame: 3 months
ED revisit: Ultrasound Qcsa plus Karnofsky Performance Score
Time frame: 3 months
Mortality: Ultrasound Qcsa plus Karnofsky Performance Score
Time frame: 3 months
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 27 Mar 2025.
- Derived from this study: PubMed 41328618Haak SL, Giezen L, Blanca D, Bouma HR, Lameijer H, Ter Maaten JC, Ter Avest E. Point-of-Care Ultrasound-Based Assessment of Sarcopenia to Predict Revisits or Mortality in Older Adults at the Emergency Department: A Prospective Observational Study. Ann Geriatr Med Res. 2026 Mar;30(1):77-84. doi: 10.4235/agmr.25.0106. Epub 2025 Nov 3.
- Individual participant dataSharing planned: No
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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.
Svenja Haak principal investigator
University Medical Center Groningen
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 and Adverse Event, run by University Medical Center Groningen at 1 site in Netherlands.
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 3 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 27 Mar 2025. 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 Netherlands. 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?
Ultrasound Qcsa (time frame: 1 day of admission to ED). The study lists 3 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 NCT05369962, 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 27 Mar 2025.