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Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study

Geriatric Assessment at Discharge From the Intensive Care Unit in Patients Aged 75 Years and Older: a Feasibility Study

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06513130
Acronym
PreGEDI
Enrollment
70
Registered
2024-07-22
Start date
2024-11-01
Completion date
2027-01-02
Last updated
2025-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Frailty, Geriatric Assessment, Older People

Brief 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 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.

Interventions

OTHERGeriatric 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.

OTHERNo geriatric assessment in the 7 days following ICU discharge.

No geriatric assessment in the 7 days following ICU discharge.

Sponsors

University Hospital, Strasbourg, France
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frame
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.At 6 Month after ICU discharge

Secondary

MeasureTime frameDescription
Frailty, assessed using the Clinical Frailty ScaleAt 6 Month after ICU discharge
Total hospital length of stayAt 6 Month after ICU discharge
At M6: main organ function assessmentAt 6 Month after ICU discharge
Number of hospitalizationAt 6 Month after ICU discharge
Regular treatment modificationsAt 6 Month after ICU dischargecollection of current treatments on admission to intensive care, on discharge from intensive care and hospitalization, and at M6 (prescription)
Modification of place of livingAt 6 Month after ICU dischargelocation (single-family dwelling, retirement home, etc.)
Rate of patients for whom consultation at M6 is carried out.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.At 6 Month after ICU dischargeFor the interventional arm
Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.At 6 Month after ICU dischargeFor the interventional arm
Evolution of the Katz-ADL score between initial assessment and month 6At 6 Month after ICU dischargeFor the interventional arm For the control arm,
Evolution of the IADL score between initial assessment and month 6At 6 Month after ICU dischargeFor the interventional arm For the control arm,
Evolution of the locomotor abilitiesAt 6 Month after ICU discharge
Evolution of cognition evaluation: mini Mental State ExaminationAt 6 Month after ICU discharge
Evolution of the quality of life assessed by the SF-36 questionnaryAt 6 Month after ICU dischargeFor the interventional arm

Countries

France

Contacts

Primary ContactJulien DEMISELLE
julien.demiselle@chru-strasbourg.fr0369551079

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026