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

• ClinicalTrials.gov Identifier: NCT06012942
• Recruitment Status: Recruiting
• First Posted: August 28, 2023
• Last Update Posted: August 28, 2023
• Sponsor: University Hospital of North Norway
• Collaborators: The Royal Norwegian Ministry of Health; Haukeland University Hospital; University Hospital, Akershus; Trondheim University Hospital; Bodø Hospital
• Information provided by (Responsible Party): University Hospital of North Norway

Tracking Information

• First Submitted Date: February 22, 2023
• First Posted Date: August 28, 2023
• Last Update Posted Date: August 28, 2023
• Actual Study Start Date: July 7, 2022
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 21, 2023)

• Change in Clinical frailty score [ Time Frame: Change in Clinical Frailty score from 3 months to 12 months follow up ]
  Score from 1 to 9.
• EuroQol 5-Dimension 5-Level (EQ-5D-5L) [ Time Frame: Change in EQ-5D-5L from 3 months to 12 months ]
  The scale measures quality of life on a 5-component scale
• Mortality [ Time Frame: ICU-stay or subsequent 12 months. ]
  Mortality during ICU-stay or subsequent 12 months.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: August 21, 2023)

• ICU readmission [ Time Frame: Long-term follow up (1 yr) ]
  ICU readmission rate
• ICU-LOS [ Time Frame: Through total ICU stay, up to 3 months ]
  ICU length of stay
• Treatment intensity level [ Time Frame: From inclusion in the study to discharge from intensive care unit, up to three months. ]
  ICU treatment intensity level

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients
• Official Title: Prevalence and Long Term Effects of Frailty in Elderly Intensive Care Patients

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.

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Frailty
• Critical Illness

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

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.
• 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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 21, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 31, 2025
• Estimated Primary Completion Date: December 31, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Bjørn A Kroken, MD; 77669863 ext +47; bjorn.anders.kroken@unn.no

Contact: Shirin K Frisvold, MD/PhD; 77669605 ext +47; shirin.kordasti@unn.no

• Listed Location Countries: Norway

Administrative Information

• NCT Number: NCT06012942
• Other Study ID Numbers: HNF1632-22
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported, after deidentification (text, tables, figures and appendices).
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (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.

• Current Responsible Party: University Hospital of North Norway
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital of North Norway
• Original Study Sponsor: Same as current

Collaborators

• The Royal Norwegian Ministry of Health
• Haukeland University Hospital
• University Hospital, Akershus
• Trondheim University Hospital
• Bodø Hospital

Investigators

• Principal Investigator: Shirin K Frisvold, MD/PhD; University Hospital of North Norway

• PRS Account: University Hospital of North Norway
• Verification Date: February 2023