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

NCT ID: NCT03789305

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 731 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2018-05-31

Brief 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.

Detailed 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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critically ill patients

Critically ill patients admitted to intensive care for more than 48 hours

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• intensive care stay > 48 hours

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Stefan Schaller

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefan J Schaller, MD, MHBA

Role: PRINCIPAL_INVESTIGATOR

Technical University of Munich

Locations

Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Munich, Bavaria, Germany

Countries

Germany

References

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.

Reference Type: BACKGROUND

PMID: 23395245 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28936626 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28289812 (View on PubMed)

Other Identifiers

DEFAULT

Identifier Type: -

Identifier Source: org_study_id