Clinical trial NCT03789305: Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
Official title: Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critical Care
Rehabilitation
Outcome Assessment
Critical Illness
Frailty
Physical and Rehabilitation Medicine
Exercise Therapy
Intensive Care Unit
Keywords: Early Mobilization
Early Rehabilitation
Functional Status
Functional Outcome
Patient Outcome
Intensive Care
Critical Care Outcomes
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2018-12-28
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients admitted to two intensive care units at a university hospital from the Department of Anesthesiology and Intensive Care in Munich, Germany.

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.

Eligibility criteria: Inclusion Criteria:

* intensive care stay \> 48 hours

Exclusion Criteria:

* none

Primary outcomes:
measure: Probability not to deteriorate in functional status during the hospital stay
timeFrame: a median of 30 days
Secondary outcomes:
measure: Change in Functional status before hospital admission to ICU discharge
timeFrame: a median of 20 days
measure: Change in Functional status before hospital admission to hospital discharge
timeFrame: a median of 30 days
measure: ICU length of stay
timeFrame: a median of 11 days
measure: Hospital length of stay
timeFrame: a median of 30 days
measure: Rate of discharge disposition to home
timeFrame: 1 day
measure: ICU mortality
timeFrame: a median of 11 days
measure: Hospital mortality
timeFrame: a median of 22 days
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum rechts der Isar, School of Medicine, Technical University of Munich
state: Bavaria
Study officials:
affiliation: Technical University of Munich
name: Stefan J Schaller, MD, MHBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.