Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients

NCT06012942 | Unknown

• 1 other identifier: HNF1632-22
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 5

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.

Conditions

Frailty; Critical Illness

Keywords

clinical frailty scale; mechanical ventilation; elderly; EQ-5D-5L

Outcome Measures

Primary Outcomes (3)

• Change in Clinical frailty score

  Score from 1 to 9.

  Change in Clinical Frailty score from 3 months to 12 months follow up

• EuroQol 5-Dimension 5-Level (EQ-5D-5L)

  The scale measures quality of life on a 5-component scale

  Change in EQ-5D-5L from 3 months to 12 months

• Mortality

  Mortality during ICU-stay or subsequent 12 months.

  ICU-stay or subsequent 12 months.

Secondary Outcomes (3)

• ICU readmission

  Long-term follow up (1 yr)

• ICU-LOS

  Through total ICU stay, up to 3 months

• Treatment intensity level

  From inclusion in the study to discharge from intensive care unit, up to three months.

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital of North Norway: lead
• The Royal Norwegian Ministry of Health: collaborator
• Haukeland University Hospital: collaborator
• University Hospital, Akershus: collaborator
• Trondheim University Hospital: collaborator
• Bodø Hospital: collaborator

Study Sites (5)

Akershus University hospital, General Intensive care department

Lørenskog, Nordbyhagen, 1478, Norway

RECRUITING

Haukeland University hospital, General Intensive care unit

Bergen, 5021, Norway

RECRUITING

Nordlandssykehuset Bodø, Intensivavdelingen

Bodø, 8005, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9038, Norway

RECRUITING

Trondheim University hospital, General Intensive care department

Trondheim, 7006, Norway

RECRUITING

Related Publications (3)

• 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.

  PMID: 28936626 BACKGROUND

• 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.

  PMID: 32868042 BACKGROUND

• Kroken BA, Bergum D, Berg KS, Espinasse M, Fossum OK, Garratt AM, Klepstad P, Kvale R, Strand B, Flaatten HK, Frisvold SK. Frailty and health-related life quality in long-term follow up of intensive care patients above 65 years old: Protocol for a Norwegian prospective, observational multicenter study. Acta Anaesthesiol Scand. 2024 Nov;68(10):1595-1600. doi: 10.1111/aas.14532. Epub 2024 Oct 1.

  PMID: 39353584 DERIVED

MeSH Terms

Conditions

Frailty; Critical Illness

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Shirin K Frisvold, MD/PhD

  University Hospital of North Norway

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bjørn A Kroken, MD

CONTACT

77669863; bjorn.anders.kroken@unn.no

Shirin K Frisvold, MD/PhD

CONTACT

77669605; shirin.kordasti@unn.no

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: August 28, 2023
• Study Start: July 7, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2025
• Last Updated: August 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 12 months and ending 5 years following article publication.
• Access Criteria: The presented dataset will be considered available from the corresponding author on reasonable request based on formal national approvals.

Locations

NO (5)