NCT03789305

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
731

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 28, 2018

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

December 25, 2018

Last Update Submit

January 19, 2019

Conditions

Critical CareRehabilitationOutcome AssessmentCritical IllnessFrailtyPhysical and Rehabilitation MedicineExercise TherapyIntensive Care Unit

Keywords

Early MobilizationEarly RehabilitationFunctional StatusFunctional OutcomePatient OutcomeIntensive CareCritical Care Outcomes

Outcome Measures

Primary Outcomes (1)

  • Probability not to deteriorate in functional status during the hospital stay

    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.

    a median of 30 days

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Critically ill patients

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • intensive care stay \> 48 hours

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Munich, Bavaria, 81675, Germany

Location

Related Publications (3)

  • Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet. 2013 Mar 2;381(9868):752-62. doi: 10.1016/S0140-6736(12)62167-9. Epub 2013 Feb 8.

    PMID: 23395245BACKGROUND

  • Flaatten H, De Lange DW, Morandi A, Andersen FH, Artigas A, Bertolini G, Boumendil A, Cecconi M, Christensen S, Faraldi L, Fjolner J, Jung C, Marsh B, Moreno R, Oeyen S, Ohman CA, Pinto BB, Soliman IW, Szczeklik W, Valentin A, Watson X, Zaferidis T, Guidet B; VIP1 study group. The impact of frailty on ICU and 30-day mortality and the level of care in very elderly patients (>/= 80 years). Intensive Care Med. 2017 Dec;43(12):1820-1828. doi: 10.1007/s00134-017-4940-8. Epub 2017 Sep 21.

    PMID: 28936626BACKGROUND

  • Latronico N, Herridge M, Hopkins RO, Angus D, Hart N, Hermans G, Iwashyna T, Arabi Y, Citerio G, Ely EW, Hall J, Mehta S, Puntillo K, Van den Hoeven J, Wunsch H, Cook D, Dos Santos C, Rubenfeld G, Vincent JL, Van den Berghe G, Azoulay E, Needham DM. The ICM research agenda on intensive care unit-acquired weakness. Intensive Care Med. 2017 Sep;43(9):1270-1281. doi: 10.1007/s00134-017-4757-5. Epub 2017 Mar 13.

    PMID: 28289812BACKGROUND

MeSH Terms

Conditions

Critical IllnessFrailty

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stefan J Schaller, MD, MHBA

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 28, 2018

Study Start

April 1, 2017

Primary Completion

May 31, 2018

Study Completion

May 31, 2018

Last Updated

January 23, 2019

Record last verified: 2019-01

Locations

DE(1)