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

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ClinicalTrials.gov Identifier: NCT03789305
Recruitment Status : Completed
First Posted : December 28, 2018
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Stefan Schaller, Technische Universität München

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.

Condition or disease
Critical Care Rehabilitation Outcome Assessment Critical Illness Frailty Physical and Rehabilitation Medicine Exercise Therapy Intensive Care Unit

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.


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Study Type : Observational
Actual Enrollment : 731 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Differences in Frail and Non-frail Critically-ill Patients in Functional Outcomes
Actual Study Start Date : April 1, 2017
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : May 31, 2018

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



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Change in Functional status before hospital admission to ICU discharge [ Time Frame: 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.

  2. Change in Functional status before hospital admission to hospital discharge [ Time Frame: 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.

  3. ICU length of stay [ Time Frame: a median of 11 days ]
    Duration of stay on intensive care

  4. Hospital length of stay [ Time Frame: a median of 30 days ]
    Duration of stay in the hospital

  5. Rate of discharge disposition to home [ Time Frame: 1 day ]
    Rate of participants being discharged home after the hospital stay.

  6. ICU mortality [ Time Frame: a median of 11 days ]
    Expired during the intensive care stay

  7. Hospital mortality [ Time Frame: a median of 22 days ]
    Expired during the hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • intensive care stay > 48 hours

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03789305


Locations
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Germany
Klinikum rechts der Isar, School of Medicine, Technical University of Munich
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Technische Universität München
Investigators
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Principal Investigator: Stefan J Schaller, MD, MHBA Technische Universität München

Publications:
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Responsible Party: Stefan Schaller, Principal Investigator, Technische Universität München
ClinicalTrials.gov Identifier: NCT03789305     History of Changes
Other Study ID Numbers: DEFAULT
First Posted: December 28, 2018    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Anonymized data will be made available to other researchers on reasonable request. A data share agreement will have to be signed by both parties.

Examples of reasonable requests are:

  • a metaanalysis in the field
  • a research collaboration
  • rerun the analysis Data will only be provided for the purpose requested and may not be used otherwise without authorization/agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stefan Schaller, Technische Universität München:
Early Mobilization
Early Rehabilitation
Functional Status
Functional Outcome
Patient Outcome
Intensive Care
Critical Care Outcomes
Additional relevant MeSH terms:
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Critical Illness
Frailty
Disease Attributes
Pathologic Processes