Skip to main content
OpenTrials
Completed

NCT Number: NCT03789305

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Critical Care Critical Illness Disease Attributes Exercise Therapy Frailty Intensive Care Unit Outcome Assessment Pathologic Processes Pathological Conditions, Signs and Symptoms Physical and Rehabilitation Medicine Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum rechts der Isar, School of Medicine, Technical University of Munich

Munich, Bavaria, 81675, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • intensive care stay > 48 hours

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Technical University of Munich

Other

Registry information

Acronym: DEFAULT

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 28, 2018
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.