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FrailtySkrIntNCT06012942

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

An observational study of Frailty and Critical Illness, run by University Hospital of North Norway at 5 sites in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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). Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Frailty, Critical Illness
How many people
300 participants
Where
5 sitesNorway
Study dates
7 Jul 2022to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Study population: ICU patients above 65 years old requiring invasive mechanical ventilation> 24 hours are screened for inclusion during the intensive care stay.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

5 sites in 1 country.

Bjørn A Kroken, MD contact

77669863 ext. +47

bjorn.anders.kroken@unn.no

Shirin K Frisvold, MD/PhD contact

77669605 ext. +47

shirin.kordasti@unn.no

5 sites in 1 country

Norway5 sites, 5 recruiting

  • Haukeland University hospital, General Intensive care unit

    Bergen, 5021

    Reidar Kvåle, MD7PhD, reidar.kvale@helse-bergen.no

    Recruiting

  • Nordlandssykehuset Bodø, Intensivavdelingen

    Bodø, 8005

    Kristin S Berg, MD/PhD, kristin.berg2@nordlandssykehuset.no

    Recruiting

  • Akershus University hospital, General Intensive care department

    Lørenskog, Nordbyhagen, 1478

    Ole Kristian Fossum, MD/PhD, Ole.Kristian.Fossum@ahus.no

    Recruiting

  • University Hospital of North Norway

    Tromsø, 9038

    Bjørn A Kroken, MD, 97514485 ext. +47, bjorn.anders.kroken@unn.no

    Recruiting

  • Trondheim University hospital, General Intensive care department

    Trondheim, 7006

    Daniel Bergum, MD/PhD, Daniel.Bergum@stolav.no

    Recruiting

Other trials in Norway

About this study

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.

Read the 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.

Keywords
clinical frailty scale, mechanical ventilation, elderly, EQ-5D-5L
Medical subject headings
Frailty, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Clinical frailty score

    Score from 1 to 9.

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

  2. EuroQol 5-Dimension 5-Level (EQ-5D-5L)

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

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

  3. Mortality

    Mortality during ICU-stay or subsequent 12 months.

    Measured: ICU-stay or subsequent 12 months.

Secondary outcomes (3)

  1. ICU readmission

    ICU readmission rate

    Measured: Long-term follow up (1 yr)

  2. ICU-LOS

    ICU length of stay

    Measured: Through total ICU stay, up to 3 months

  3. Treatment intensity level

    ICU treatment intensity level

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2023
  2. Study start7 Jul 2022
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06012942
Sponsor's protocol ID
HNF1632-22
Acronym
SkrInt
Status last verified
Feb 2023
First submitted
22 Feb 2023
Last updated
28 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices).

Publications

  • 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.

    PubMed 28936626

  • 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.

    PubMed 32868042

  • Kroken BA, Bergum D, Berg KS, Espinasse M, Fossum OK, Hoff M, Klepstad P, Sjobo BA, Kvale R, Flaatten H, Frisvold SK. Long-term frailty trajectory in older ICU survivors requiring mechanical ventilation: a prospective cohort study in Norway. Ann Intensive Care. 2026 Jul 16;16:100115. doi: 10.1016/j.aicoj.2026.100115. eCollection 2026.

    PubMed 42565125

  • 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.

    PubMed 39353584

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Critical Illness, run by University Hospital of North Norway at 5 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bjørn A Kroken, MD (77669863 ext. +47, bjorn.anders.kroken@unn.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Clinical frailty score (time frame: Change in Clinical Frailty score from 3 months to 12 months follow up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06012942, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.

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