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Clinical Trials/NCT03789305
NCT03789305
Completed
Not Applicable

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

Technical University of Munich1 site in 1 country731 target enrollmentApril 1, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Care
Sponsor
Technical University of Munich
Enrollment
731
Locations
1
Primary Endpoint
Probability not to deteriorate in functional status during the hospital stay
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2017
End Date
May 31, 2018
Last Updated
7 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Technical University of Munich
Responsible Party
Principal Investigator
Principal Investigator

Stefan Schaller

Principal Investigator

Technical University of Munich

Eligibility Criteria

Inclusion Criteria

  • intensive care stay \> 48 hours

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Probability not to deteriorate in functional status during the hospital stay

Time Frame: 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 Outcomes

  • Change in Functional status before hospital admission to ICU discharge(a median of 20 days)
  • Change in Functional status before hospital admission to hospital discharge(a median of 30 days)
  • ICU length of stay(a median of 11 days)
  • Hospital length of stay(a median of 30 days)
  • Rate of discharge disposition to home(1 day)
  • ICU mortality(a median of 11 days)
  • Hospital mortality(a median of 22 days)

Study Sites (1)

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