Critical Illness Clinical Trial
— SkrIntOfficial title:
Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
NCT number | NCT06012942 |
Other study ID # | HNF1632-22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 7, 2022 |
Est. completion date | December 31, 2025 |
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 65 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Norway | Haukeland University hospital, General Intensive care unit | Bergen | |
Norway | Nordlandssykehuset Bodø, Intensivavdelingen | Bodø | |
Norway | Akershus University hospital, General Intensive care department | Lørenskog | Nordbyhagen |
Norway | University Hospital of North Norway | Tromsø | |
Norway | Trondheim University hospital, General Intensive care department | Trondheim |
Lead Sponsor | Collaborator |
---|---|
University Hospital of North Norway | Bodø Hospital, Haukeland University Hospital, The Royal Norwegian Ministry of Health, Trondheim University Hospital, University Hospital, Akershus |
Norway,
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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Clinical frailty score | Score from 1 to 9. | Change in Clinical Frailty score from 3 months to 12 months follow up | |
Primary | 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 | |
Primary | Mortality | Mortality during ICU-stay or subsequent 12 months. | ICU-stay or subsequent 12 months. | |
Secondary | ICU readmission | ICU readmission rate | Long-term follow up (1 yr) | |
Secondary | ICU-LOS | ICU length of stay | Through total ICU stay, up to 3 months | |
Secondary | Treatment intensity level | ICU treatment intensity level | From inclusion in the study to discharge from intensive care unit, up to three months. |
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