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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03789305
Acronym
DEFAULT
Enrollment
731
Registered
2018-12-28
Start date
2017-04-01
Completion date
2018-05-31
Last updated
2019-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Early Mobilization, Early Rehabilitation, Functional Status, Functional Outcome, Patient Outcome, Intensive Care, Critical Care Outcomes

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.

Interventions

None listed

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* intensive care stay \> 48 hours

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Probability not to deteriorate in functional status during the hospital staya median of 30 daysAnalysis 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.

Secondary

MeasureTime frameDescription
Hospital length of staya median of 30 daysDuration of stay in the hospital
Rate of discharge disposition to home1 dayRate of participants being discharged home after the hospital stay.
ICU mortalitya median of 11 daysExpired during the intensive care stay
ICU length of staya median of 11 daysDuration of stay on intensive care
Change in Functional status before hospital admission to ICU dischargea median of 20 daysAnalysis 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.
Change in Functional status before hospital admission to hospital dischargea median of 30 daysAnalysis 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.
Hospital mortalitya median of 22 daysExpired during the hospital stay

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026