Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes

Critical Illness Clinical Trial

— DEFAULT  

Official title:

Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03789305
• Other study ID #: DEFAULT
• Status: Completed
• Start date: April 1, 2017
• Est. completion date: May 31, 2018

Study information

• Verified date: January 2019
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is a prospective analysis of patient registry data of intensive care patients. The aim is to investigate if frailty is a predictor of decline of functional status of critically ill patients during their hospital stay.

Description:

Elderly critical-ill patients with a high frailty level are becoming increasingly important in the ICU and the health system. Especially, questions about the course of the individual proceeding, withhold of therapy and level of care are controversial among caretakers, as outcome and functional independence remain still unclear in these patients.

This applies particularly in view of the fact that large studies such as VIP1 showed an inverse association of high frailty classes with short-term survival.

Our main objective in this study was to focus on functional outcome and independency measured by Barthel Index after ICU stay regarding frailty, the effect of critical care and severity and prognosis of the disease.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 731
• Est. completion date: May 31, 2018
• Est. primary completion date: May 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• intensive care stay > 48 hours

Exclusion Criteria:

Related Conditions & MeSH terms

• Critical Care
• Critical Illness
• Exercise Therapy
• Frailty
• Intensive Care Unit
• Outcome Assessment
• Physical and Rehabilitation Medicine
• Rehabilitation

Locations

Country	Name	City	State
Germany	Klinikum rechts der Isar, School of Medicine, Technical University of Munich	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8. Review. Erratum in: Lancet. 2013 Oct 19;382(9901):1328. — View Citation

Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjølner J, Jung C, Marsh B, Moreno R, Oeyen S, Öhman 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

Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probability not to deteriorate in functional status during the hospital stay	Analysis of the course of functional status measured by the Barthel Score sub-components transfer and ambulation during the hospital stay. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.	a median of 30 days
Secondary	Change in Functional status before hospital admission to ICU discharge	Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to ICU discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.	a median of 20 days
Secondary	Change in Functional status before hospital admission to hospital discharge	Analysis of the change of functional status measured by the Barthel Score sub-components transfer and ambulation from before hospital admission to hospital discharge. The Scale ranges from 0 (no transfer) to 15 (transfer to chair and back) for transfer and from 0 (no ambulation) to 15 (coming into stand and walk 50m without supervision) for ambulation.	a median of 30 days
Secondary	ICU length of stay	Duration of stay on intensive care	a median of 11 days
Secondary	Hospital length of stay	Duration of stay in the hospital	a median of 30 days
Secondary	Rate of discharge disposition to home	Rate of participants being discharged home after the hospital stay.	1 day
Secondary	ICU mortality	Expired during the intensive care stay	a median of 11 days
Secondary	Hospital mortality	Expired during the hospital stay	a median of 22 days