Clinical trial NCT06012942: Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
Official title: Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Frailty
Critical Illness
Keywords: clinical frailty scale
mechanical ventilation
elderly
EQ-5D-5L
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
Collaborators: name: The Royal Norwegian Ministry of Health
name: Haukeland University Hospital
name: University Hospital, Akershus
name: Trondheim University Hospital
name: Bodø Hospital
First posted: 2023-08-28
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICU patients above 65 years old requiring invasive mechanical ventilation\> 24 hours are screened for inclusion during the intensive care stay.

Brief summary: The primary aim is to study change of critical frailty scale (CFS) and health related quality of life (EQ-5D-5L) in a long-term follow-up of ICU survivors. We aim to identify important ICU related predictors for change in CFS and EQ-5D-5L in long term follow up (1 yr).

Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.

Detailed description: This is a multi-centre norwegian observational, prospective multicenter Norway coordinated from University hospital North Norway, Tromso.

The study is approved by The Regional Committee for Medical Research Ethics Northern Norway.

The following scores will be assessed by asking the patient and relative during ICU stay: CFS, EQ5DL before current critical illness.

The following demographic and clinical data will be retrieved from the medical records: Comorbidity before critical illness, reasons for ICU admission, daily severity score (SOFA- score), length of mechanical ventilation, dialysis, tracheostomy, Habitat before and after ICU treatment, ICU and hospital length of stay, complications retrieved during intensive care treatment, mortality, limitation of treatment.

The patients will be followed up with telephone interview after hospital discharge for evaluation of: Comorbidity, CFS, EQ5DData for all sites are collected and managed using RedCap electronic data capture tools.

Three research nurses will do the follow up with telephone interviews on all sites and record the data in RedCap.

We aim to enroll 300 patients before 31. Des 2024.

Eligibility criteria: Inclusion Criteria:

* \>= 65 years
* ≥ 24 hours mechanical ventilation
* Written informed consent from patient or next of kin

Exclusion Criteria:

* Readmission of patient included in the study
* Not possible to obtain a valid CFS or and EQ-5D-5L at admission or follow-up of CFS because of social context or language.

Primary outcomes:
measure: Change in Clinical frailty score
timeFrame: Change in Clinical Frailty score from 3 months to 12 months follow up
measure: EuroQol 5-Dimension 5-Level (EQ-5D-5L)
timeFrame: Change in EQ-5D-5L from 3 months to 12 months
measure: Mortality
timeFrame: ICU-stay or subsequent 12 months.
Secondary outcomes:
measure: ICU readmission
timeFrame: Long-term follow up (1 yr)
measure: ICU-LOS
timeFrame: Through total ICU stay, up to 3 months
measure: Treatment intensity level
timeFrame: From inclusion in the study to discharge from intensive care unit, up to three months.
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University hospital, General Intensive care department
state: Nordbyhagen
city: Bergen
country: Norway
facility: Haukeland University hospital, General Intensive care unit
city: Bodø
country: Norway
facility: Nordlandssykehuset Bodø, Intensivavdelingen
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: Trondheim University hospital, General Intensive care department
Study officials:
affiliation: University Hospital of North Norway
name: Shirin K Frisvold, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.
citation: Flaatten H, Beil M, Guidet B. Prognostication in older ICU patients: mission impossible? Br J Anaesth. 2020 Nov;125(5):655-657. doi: 10.1016/j.bja.2020.08.005. Epub 2020 Aug 14. No abstract available.