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NCT Number: NCT06513130

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

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.

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Key information

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de Médecine Intensive - Réanimation / CHU Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Julien DEMISELLE

CONTACT

[email protected]

0369551079 ext. +33

Julien DEMISELLE

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of patients for whom consultation at M6 is carried out.

    Time frame: At 6 Month after ICU discharge

  2. Frailty, assessed using the Clinical Frailty Scale

    Time frame: At 6 Month after ICU discharge

  3. Total hospital length of stay

    Time frame: At 6 Month after ICU discharge

  4. Number of hospitalization

    Time frame: At 6 Month after ICU discharge

  5. Regular treatment modifications

    Time frame: At 6 Month after ICU discharge

    collection of current treatments on admission to intensive care, on discharge from intensive care and hospitalization, and at M6 (prescription)

  6. Modification of place of living

    Time frame: At 6 Month after ICU discharge

    location (single-family dwelling, retirement home, etc.)

  7. Evolution of the quality of life assessed by the SF-36 questionnary

    Time frame: At 6 Month after ICU discharge

    For the interventional arm

  8. 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

    For the interventional arm

  9. Evolution of the psychological behaviours through the Covi test evolution for the anxiety component.

    Time frame: At 6 Month after ICU discharge

    For the interventional arm

  10. Evolution of the Katz-ADL score between initial assessment and month 6

    Time frame: At 6 Month after ICU discharge

    For the interventional arm For the control arm,

  11. Evolution of the IADL score between initial assessment and month 6

    Time frame: At 6 Month after ICU discharge

    For the interventional arm For the control arm,

  12. Evolution of the locomotor abilities

    Time frame: At 6 Month after ICU discharge

  13. Evolution of cognition evaluation: mini Mental State Examination

    Time frame: At 6 Month after ICU discharge

  14. At M6: main organ function assessment

    Time frame: At 6 Month after ICU discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Julien DEMISELLE

CONTACT

[email protected]

0369551079 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: PreGEDI

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 22, 2024
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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