Prospective Registry of Mobilization-, Routine- and Outcome Data of Intensive Care Patients

Active, not recruiting

• Conditions: Critical Care; Rehabilitation; Outcome Assessment (Health Care)

• Registration Number: NCT03666286
• Lead Sponsor: Technical University of Munich

Brief Summary

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

Detailed Description

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

The database is supposed to help quality improvement as well as

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-07
• Study First Posted: 2018-09-11
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-21
• Last Update Posted: 2023-11-22
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 10000

Inclusion Criteria

• Intensive care unit stay > 24 hours

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physical Function at hospital discharge	At hospital discharge, on average within 1 month	Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs

Secondary Outcome Measures

Name	Time	Method
Cognitive Function	180 and 360 days after ICU discharge	Cognitive Function assessed with the MoCA blind (Montreal Cognitive Assessment)
ICU Mortality	At ICU Discharge, on average within 2 weeks	ICU Mortality
Hospital Mortality	At hospital discharge, on average within 1 month	Hospital Mortality
Pre-ICU Function	2 weeks before ICU admission	Pre-ICU Function assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule), EQ5D (European Quality of Life 5 Dimensions 5 Level) and work details
Quality of Life of the patient	180 and 360 days after ICU discharge	Quality of Life of the patient assessed with the EQ5D (European Quality of Life 5 Dimensions 5 Level)
Anxiety and Depression	180 and 360 days after ICU discharge	Anxiety and Depression assessed with the IES-R (Impact of Event Scale - Revised) and HADS (Hospital Anxiety and Depression scale)
Physical function of the patient	180 and 360 days after ICU discharge	Physical function of the patient assessed with the IADL (The Lawton Instrumental Activities of Daily Living)
Global function of the patient	180 and 360 days after ICU discharge	Global function of the patient assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)
Return to work	180 and 360 days after ICU discharge	Return to work assessed with the WHODAS 2.0 (World Health Organisation's Disability Assessment Schedule)
Physical function at ICU discharge	At ICU Discharge, on average within 2 weeks	Physical function at ICU discharge with either the mmFIM (minimal modified Functional Independence Measure) or the Barthel subdomains transfer, locomotion and climbing stairs

Trial Locations

Locations (1)

Klinikum rechts der Isar der TUM; 🇩🇪 Munich, Bavaria, Germany