Critical IllnessPreGEDINCT06513130
Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study
A study testing Geriatric assessment in the 7 days following ICU discharge. and No geriatric assessment in the 7 days following ICU discharge. in people with Critical Illness and Geriatric Assessment, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of… Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Critical Illness, Geriatric Assessment, Older People
- What is being tested?
- Geriatric assessment in the 7 days following ICU discharge. and No geriatric assessment in the 7 days following ICU discharge.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 2 Jan 2027
- Phase
- Interventional
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients over 75 years of age
- Admitted to the intensive care unit, for whatever reason, and having survived their stay, considered as leaving the intensive care unit.
- Subjects affiliated to a health insurance scheme
- Able to understand the aims and risks of the research and to give dated, signed informed consent,
- In the event of confusion on leaving the intensive care unit, a close relative available to give dated, signed informed consent, with the patient's consent collected as soon as his or her condition permits.
Who cannot join
- Protected subject as defined by law: safeguard of justice, guardianship or curatorship procedures
- Subject moribund, or whose life expectancy as estimated by the clinician in charge is less than 1 month
- Patient not living in Bas-Rhin (visit to M6)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service de Médecine Intensive - Réanimation / CHU Strasbourg - France
Strasbourg, 67091
Julien DEMISELLE, 0369551079 ext. +33, julien.demiselle@chru-strasbourg.fr
Julien DEMISELLE
About this study
The number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of critical care admissions, depending on the facility.
The admission of these patients remains controversial, with questions about the benefit to elderly patients, both in terms of in-hospital and distant survival, as well as induced morbidity or subsequent quality of life: functional status is impaired in up to two-thirds of survivors.
Read more
The challenge of identifying the patients most able to withstand a stay is a major one. Indeed, a stay in intensive care represents a major stress for the organism, due to the acute condition associated with one or more organ failure(s). Bed rest, immobilization and the use of drugs are responsible for formidable complications in the elderly: muscle-wasting, loss of adaptation to physical effort, loss of autonomy, delirium and agitation, all of which have their own long-term impact.
While many studies have looked at the prognostic factors on admission of these patients, and the selection of the patient with the greatest probability of surviving the intensive care unit (ICU), improving the outcome of patients who survive to the ICU stay remains a little-investigated subject. However, the impact of physical and psychological disturbances induced by these patients' stay in intensive care is major, and their detection and management could be elements of interest in improving the care of this population. However, the feasibility of carrying out such an assessment immediately after an ICU stay has yet to be evaluated. The aim of this study would be to evaluate the feasibility of a geriatric assessment at the end of the ICU stay (or within 7 days of discharge) and at 6 months. This study is a prospective, randomized, single-center, open-label interventional study.
- Conditions
- Critical Illness, Geriatric Assessment, Older People, Frailty
- Being tested
- Geriatric assessment in the 7 days following ICU discharge., No geriatric assessment in the 7 days following ICU discharge.
- Medical subject headings
- Critical Illness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric assessment in the 7 days following ICU discharge.Other
ICU survivors will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following ICU discharge.
No geriatric assessment in the 7 days following ICU discharge.Other
No geriatric assessment in the 7 days following ICU discharge.
| Study group | Role | What they receive |
|---|---|---|
| Group with geriatric assessment | Experimental | Patients will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following.
In addition to the first visit in the group "without geriatric assessment", will be collected:
* Living conditions (home, proxy, home support)
* Quality of life (SF-36)
* Covi test and 4-item Geriatric Depression Scale
* Katz-ADL and IADL
* History of fall, mobility assessment
* Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment)
* Cognitive assessment (Mini-mental State Examination)
The visit at month 6 will be the same in both groups Receives: Other: Geriatric assessment in the 7 days following ICU discharge. |
| Group without geriatric assessment | Active comparator | At the end of the ICU stay or in the 7 days following, will be collect:
* Medical and surgical history, Charlson comorbidity index,
* Living place
* Regular treatment (number and class)
* ICU trajectory: ICU length of stay, reason for ICU admission, severity scores (SOFA and SAPS 2 score), organ supports requirement and duration
* Limitation of life-sustaining therapy decision
At 6 month after ICU discharge, patients will be evaluated during a post-ICU consultation, where will be recorded:
* Living conditions (home, proxy, home support)
* Quality of life (SF-36)
* Covi test and 4-item Geriatric Depression Scale
* Katz-ADL and IADL
* History of fall, mobility assessment
* Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment)
* Cognitive assessment (Mini-mental State Examination)
* Regular treatment (number and class)
* Hospitalizations between ICU discharge and M6
* Additional comorbidity
* Family burden assessment (mini-Zarit) Receives: Other: No geriatric assessment in the 7 days following ICU discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients for whom a geriatric assessment is carried out between the end of their stay in intensive care and 7 days after discharge.
Measured: At 6 Month after ICU discharge
Secondary outcomes (14)
Rate of patients for whom consultation at M6 is carried out.
Measured: At 6 Month after ICU discharge
Frailty, assessed using the Clinical Frailty Scale
Measured: At 6 Month after ICU discharge
Total hospital length of stay
Measured: At 6 Month after ICU discharge
Number of hospitalization
Measured: At 6 Month after ICU discharge
Regular treatment modifications
collection of current treatments on admission to intensive care, on discharge from intensive care and hospitalization, and at M6 (prescription)
Measured: At 6 Month after ICU discharge
Modification of place of living
location (single-family dwelling, retirement home, etc.)
Measured: At 6 Month after ICU discharge
Evolution of the quality of life assessed by the SF-36 questionnary
For the interventional arm
Measured: At 6 Month after ICU discharge
Evolution of the psychological behaviours through the mini Geriatric depression score evolution and the Covi test evolution for the anxiety component.
For the interventional arm
Measured: At 6 Month after ICU discharge
Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.
For the interventional arm
Measured: At 6 Month after ICU discharge
Evolution of the Katz-ADL score between initial assessment and month 6
For the interventional arm For the control arm,
Measured: At 6 Month after ICU discharge
Evolution of the IADL score between initial assessment and month 6
For the interventional arm For the control arm,
Measured: At 6 Month after ICU discharge
Evolution of the locomotor abilities
Measured: At 6 Month after ICU discharge
Evolution of cognition evaluation: mini Mental State Examination
Measured: At 6 Month after ICU discharge
At M6: main organ function assessment
Measured: At 6 Month after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start1 Nov 2024
- Primary completion2 Jan 2027 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien DEMISELLE, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06513130
- Sponsor's protocol ID
- 9107
- Acronym
- PreGEDI
- Status last verified
- Apr 2025
- First submitted
- 10 Jul 2024
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study
- ClinicalTrials.gov ID
- NCT06513130
- Acronym / sponsor ID
- PreGEDI / 9107
- Conditions
- Critical Illness, Geriatric Assessment, Older People, Frailty
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 2 Jan 2027 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 22 Jul 2024 (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 number of patients aged over 75 continues to grow, and, according to INSEE, will represent almost 10% of the French population in 2021, an increase of 2.4 points since 2000. This demographic change is also observed in the intensive care units, where admitted patients aged over 80 represent now up to 10-20% of critical care admissions, depending on the facility.
The admission of these patients remains controversial, with questions about the benefit to elderly patients, both in terms of in-hospital and distant survival, as well as induced morbidity or subsequent quality of life: functional status is impaired in up to two-thirds of survivors.
The challenge of identifying the patients most able to withstand a stay is a major one. Indeed, a stay in intensive care represents a major stress for the organism, due to the acute condition associated with one or more organ failure(s). Bed rest, immobilization and the use of drugs are responsible for formidable complications in the elderly: muscle-wasting, loss of adaptation to physical effort, loss of autonomy, delirium and agitation, all of which have their own long-term impact.
While many studies have looked at the prognostic factors on admission of these patients, and the selection of the patient with the greatest probability of surviving the intensive care unit (ICU), improving the outcome of patients who survive to the ICU stay remains a little-investigated subject. However, the impact of physical and psychological disturbances induced by these patients' stay in intensive care is major, and their detection and management could be elements of interest in improving the care of this population. However, the feasibility of carrying out such an assessment immediately after an ICU stay has yet to be evaluated. The aim of this study would be to evaluate the feasibility of a geriatric assessment at the end of the ICU stay (or within 7 days of discharge) and at 6 months. This study is a prospective, randomized, single-center, open-label interventional study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with geriatric assessment | Experimental | Other: Geriatric assessment in the 7 days following ICU discharge.Patients will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following. In addition to the first visit in the group "without geriatric assessment", will be collected: * Living conditions (home, proxy, home support) * Quality of life (SF-36) * Covi test and 4-item Geriatric Depression Scale * Katz-ADL and IADL * History of fall, mobility assessment * Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment) * Cognitive assessment (Mini-mental State Examination) The visit at month 6 will be the same in both groups |
| Group without geriatric assessment | Active comparator | Other: No geriatric assessment in the 7 days following ICU discharge.At the end of the ICU stay or in the 7 days following, will be collect: * Medical and surgical history, Charlson comorbidity index, * Living place * Regular treatment (number and class) * ICU trajectory: ICU length of stay, reason for ICU admission, severity scores (SOFA and SAPS 2 score), organ supports requirement and duration * Limitation of life-sustaining therapy decision At 6 month after ICU discharge, patients will be evaluated during a post-ICU consultation, where will be recorded: * Living conditions (home, proxy, home support) * Quality of life (SF-36) * Covi test and 4-item Geriatric Depression Scale * Katz-ADL and IADL * History of fall, mobility assessment * Nutritional status (BMI, albuminemia, Mini Nutritionnal Assesment) * Cognitive assessment (Mini-mental State Examination) * Regular treatment (number and class) * Hospitalizations between ICU discharge and M6 * Additional comorbidity * Family burden assessment (mini-Zarit) |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Patients over 75 years of age
- Admitted to the intensive care unit, for whatever reason, and having survived their stay, considered as leaving the intensive care unit.
- Subjects affiliated to a health insurance scheme
- Able to understand the aims and risks of the research and to give dated, signed informed consent,
- In the event of confusion on leaving the intensive care unit, a close relative available to give dated, signed informed consent, with the patient's consent collected as soon as his or her condition permits.
Key exclusion criteria (3 listed)
- Protected subject as defined by law: safeguard of justice, guardianship or curatorship procedures
- Subject moribund, or whose life expectancy as estimated by the clinician in charge is less than 1 month
- Patient not living in Bas-Rhin (visit to M6)
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 |
|---|---|---|
| Geriatric assessment in the 7 days following ICU discharge.ICU survivors will be assessed by a geriatric physician, in a global (clinical, physical, psyochological and social) approach at the end of the ICU stay or in the 7 days following ICU discharge. | Other | Group with geriatric assessment |
| No geriatric assessment in the 7 days following ICU discharge.No geriatric assessment in the 7 days following ICU discharge. | Other | Group without geriatric assessment |
Primary outcome
Rate of patients for whom a geriatric assessment is carried out between the end of their stay in intensive care and 7 days after discharge.
Time frame: At 6 Month after ICU discharge
14 secondary outcomes
Rate of patients for whom consultation at M6 is carried out.
Time frame: At 6 Month after ICU discharge
Frailty, assessed using the Clinical Frailty Scale
Time frame: At 6 Month after ICU discharge
Total hospital length of stay
Time frame: At 6 Month after ICU discharge
Number of hospitalization
Time frame: At 6 Month after ICU discharge
Regular treatment modifications
Time frame: At 6 Month after ICU discharge
Modification of place of living
Time frame: At 6 Month after ICU discharge
Evolution of the quality of life assessed by the SF-36 questionnary
Time frame: At 6 Month after ICU discharge
Evolution of the psychological behaviours through the mini Geriatric depression score evolution and the Covi test evolution for the anxiety component.
Time frame: At 6 Month after ICU discharge
Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.
Time frame: At 6 Month after ICU discharge
Evolution of the Katz-ADL score between initial assessment and month 6
Time frame: At 6 Month after ICU discharge
Evolution of the IADL score between initial assessment and month 6
Time frame: At 6 Month after ICU discharge
Evolution of the locomotor abilities
Time frame: At 6 Month after ICU discharge
Evolution of cognition evaluation: mini Mental State Examination
Time frame: At 6 Month after ICU discharge
At M6: main organ function assessment
Time frame: At 6 Month after ICU discharge
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 29 Apr 2025.
- 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.
Julien DEMISELLE principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Geriatric assessment in the 7 days following ICU discharge. and No geriatric assessment in the 7 days following ICU discharge. in people with Critical Illness and Geriatric Assessment, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 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 29 Apr 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 France. 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 Julien DEMISELLE (0369551079 ext. +33, julien.demiselle@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients for whom a geriatric assessment is carried out between the end of their stay in intensive care and 7 days after discharge. (time frame: At 6 Month after ICU discharge). 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 29 Apr 2025.