Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
NCT ID: NCT06012942
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
300 participants
OBSERVATIONAL
2022-07-07
2025-12-31
Brief Summary
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Secondary aim is to investigate how CFS pre-admission is related to intrahospital treatment intensity level, severity score and mortality.
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* ≥ 24 hours mechanical ventilation
* Written informed consent from patient or next of kin
Exclusion Criteria
* 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.
65 Years
ALL
No
Sponsors
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The Royal Norwegian Ministry of Health
OTHER
Haukeland University Hospital
OTHER
University Hospital, Akershus
OTHER
Trondheim University Hospital
OTHER
Bodø Hospital
UNKNOWN
University Hospital of North Norway
OTHER
Responsible Party
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Principal Investigators
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Shirin K Frisvold, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital of North Norway
Locations
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Akershus University hospital, General Intensive care department
Lørenskog, Nordbyhagen, Norway
Haukeland University hospital, General Intensive care unit
Bergen, , Norway
Nordlandssykehuset Bodø, Intensivavdelingen
Bodø, , Norway
University Hospital of North Norway
Tromsø, , Norway
Trondheim University hospital, General Intensive care department
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
Other Identifiers
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HNF1632-22
Identifier Type: -
Identifier Source: org_study_id
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