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

Critical Illness Clinical Trial

— SkrInt  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06012942
• Other study ID #: HNF1632-22
• Status: Recruiting
• Start date: July 7, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2023
• Source: University Hospital of North Norway
• Contact: Bjørn A Kroken, MD
• Phone: 77669863
• Email: bjorn.anders.kroken[@]unn.no
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Critical Illness
• Frailty

Locations

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

Sponsors (6)

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

Country where clinical trial is conducted

Norway, 

References & Publications (2)

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

Outcome

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.