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

Completed

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

• Registration Number: NCT03789305
• Lead Sponsor: Technical University of Munich

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.

Study Timeline

• Study Start: 2017-04-01
• Primary Completion: 2018-05-31
• Study Completion: 2018-05-31
• Study First Submitted: 2018-12-25
• Study First Submitted QC: 2018-12-25
• Study First Posted: 2018-12-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-19
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 731

Inclusion Criteria

• intensive care stay > 48 hours

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probability not to deteriorate in functional status during the hospital stay	a median of 30 days	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.

Secondary Outcome Measures

Name	Time	Method
ICU length of stay	a median of 11 days	Duration of stay on intensive care
Change in Functional status before hospital admission to ICU discharge	a median of 20 days	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.
Change in Functional status before hospital admission to hospital discharge	a median of 30 days	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.
Hospital length of stay	a median of 30 days	Duration of stay in the hospital
Rate of discharge disposition to home	1 day	Rate of participants being discharged home after the hospital stay.
ICU mortality	a median of 11 days	Expired during the intensive care stay
Hospital mortality	a median of 22 days	Expired during the hospital stay

Trial Locations

Locations (1)

Klinikum rechts der Isar, School of Medicine, Technical University of Munich; 🇩🇪 Munich, Bavaria, Germany