NCT03666286

Brief Summary

Registry database of intensive care patients. These data comprises of routine data including mobilization data and follow up assessments.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
1,172

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

February 1, 2017

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 11, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

September 19, 2025

Status Verified

September 1, 2025

Enrollment Period

2.2 years

First QC Date

September 4, 2018

Last Update Submit

September 15, 2025

Conditions

Keywords

early mobilization, intensive care, longterm outcomes

Outcome Measures

Primary Outcomes (1)

  • Physical Function at hospital discharge

    Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs

    At hospital discharge, on average within 1 month

Secondary Outcomes (10)

  • Hospital Mortality

    At hospital discharge, on average within 1 month

  • Pre-ICU Function

    2 weeks before ICU admission

  • Global function of the patient

    180 and 360 days after ICU discharge

  • Physical function of the patient

    180 and 360 days after ICU discharge

  • Quality of Life of the patient

    180 and 360 days after ICU discharge

  • +5 more secondary outcomes

Other Outcomes (1)

  • Disability-Free survival

    180 and 360 days after ICU discharge

Study Arms (1)

Intensive Care Patients

Patients \>24h on intensive care

Eligibility Criteria

Sexall(Gender-based eligibility)
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Intensive Care Unit Patients

You may qualify if:

  • Intensive care unit stay \> 24 hours

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar der TUM

Munich, Bavaria, 81675, Germany

Location

Related Publications (2)

  • Lorenz M, Fuest K, Ulm B, Grunow JJ, Warner L, Bald A, Arsene V, Verfuss M, Daum N, Blobner M, Schaller SJ. The optimal dose of mobilisation therapy in the ICU: a prospective cohort study. J Intensive Care. 2023 Nov 20;11(1):56. doi: 10.1186/s40560-023-00703-1.

  • Fuest KE, Ulm B, Daum N, Lindholz M, Lorenz M, Blobner K, Langer N, Hodgson C, Herridge M, Blobner M, Schaller SJ. Clustering of critically ill patients using an individualized learning approach enables dose optimization of mobilization in the ICU. Crit Care. 2023 Jan 3;27(1):1. doi: 10.1186/s13054-022-04291-8.

Study Officials

  • Stefan J Schaller, MD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Specialist Intensive Care

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 11, 2018

Study Start

February 1, 2017

Primary Completion

April 30, 2019

Study Completion

November 22, 2022

Last Updated

September 19, 2025

Record last verified: 2025-09

Locations