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

NCT ID: NCT06513130

Last Updated: 2025-04-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2027-01-02

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.

Conditions

Critical Illness; Geriatric Assessment; Older People; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group with geriatric assessment

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 Type: EXPERIMENTAL

Geriatric assessment in the 7 days following ICU discharge.

Intervention Type: 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.

Group without geriatric assessment

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)

Group Type: ACTIVE_COMPARATOR

No geriatric assessment in the 7 days following ICU discharge.

Intervention Type: OTHER

No geriatric assessment in the 7 days following ICU discharge.

Interventions

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.

Intervention Type: OTHER

No geriatric assessment in the 7 days following ICU discharge.

No geriatric assessment in the 7 days following ICU discharge.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julien DEMISELLE

Role: PRINCIPAL_INVESTIGATOR

Hôpitaux Universitaires de Strasbourg

Locations

Service de Médecine Intensive - Réanimation / CHU Strasbourg - France

Strasbourg, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Julien DEMISELLE

Role: CONTACT

julien.demiselle@chru-strasbourg.fr

0369551079 ext. +33

Facility Contacts

Julien DEMISELLE

Role: primary

julien.demiselle@chru-strasbourg.fr

0369551079 ext. +33

Other Identifiers

9107

Identifier Type: -

Identifier Source: org_study_id