Medical University of Vienna
Vienna, State of Vienna, 1090, Austria
Location status: Recruiting
Location contact
Stefan J Schaller, MD
CONTACT
Vera Karner, MSc
CONTACT
Vera Karner, MSc
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06960642
Rehabilitation already begins in the intensive care unit (ICU) to maintain or restore the functional capacity of ICU patients and to counteract the long-term effects of intensive care treatment. Mobilisation is an important component.
The aim of this multinational observational study is to record and evaluate the different mobilisation practices for ICU patients worldwide. The investigators want to find out which forms of mobilisation in intensive care patients achieve the best results in terms of physical function, functional status and quality of life.
The goal is to recruit over 6,000 patients internationally. No interventions will be carried out, only routine clinical data will be documented and standardised and already established physical tests and questionnaires will be used.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Vienna, State of Vienna, 1090, Austria
Location status: Recruiting
Stefan J Schaller, MD
CONTACT
Vera Karner, MSc
CONTACT
Vera Karner, MSc
PRINCIPAL_INVESTIGATOR
Intensive care treatment can have long-term effects on patients. Around 40% of intensive care unit (ICU) patients develop an Intensive Care Unit Acquired Weakness (ICUAW), which leads to functional limitations and an impairment of independence, participation in everyday life, quality of life and ability to work. Recent studies have shown that early mobilisation has a positive effect on the course of the disease, including improved physical function and independence, shorter ventilation times, and shorter ICU and hospital stays. However, there is currently no standardised approach to mobilisation and the dosage required to achieve the best health outcomes in ICU patients is unknown. There is also a lack of data on patients who were functionally dependent before hospital admission and on patients who were not on invasive mechanical ventilation.
The main objectives of the observational study are:
The investigators aim to recruit over 6,000 patients internationally from a minimum of 200 intensive care units. The total duration of the study is 21 months, with participation per patients being 90 days. Routine clinical data and mobilisation data from ICU will be documented, and standardised functional tests and questionnaires will be conducted.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: ICU discharge (up to Day 28)
Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function.
Time frame: ICU discharge (up to Day 28) and Day 90
Highest level of mobility measured with the ICU Mobility Scale (IMS). The scale ranges from 0 to 10, with higher scores indicating a higher level of mobility (up to independent walking).
Time frame: Day 90
Physical function measured with the Functional Status Score for the Intensive Care Unit (FSS-ICU). The total score ranges from 0 to 35, with higher scores indicating better physical function.
Time frame: ICU discharge (up to Day 28) and Day 90
Frailty/ Functional status measured with the Clinical Frailty Scale (CFS). The scale ranges from 1 (very fit) to 9 (terminally ill), with higher scores indicating a higher degree of frailty.
Time frame: ICU admission until ICU discharge (up to Day 28)
Length of stay in the ICU
Time frame: ICU admission until hospital discharge
Length of stay in the hospital
Time frame: ICU admission until ICU discharge (up to Day 28)
Mortality during ICU stay
Time frame: ICU admission until hospital discharge
Mortality during hospital stay
Time frame: Day 90
Mortality at day 90
Time frame: Day 90
Disability measured with the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0, 12-item version). Each item is rated on a scale from 1 (no difficulty) to 5 (extreme or cannot do), with higher scores indicating greater disability.
Time frame: ICU discharge (up to Day 28) and Day 90
Activities of Daily Living (ADLs) measured with the Barthel Score. The total score ranges from 0 to 100, with higher scores indicating less assistance and greater independence in performing ADLs.
Contact information is provided by the study sponsor or research team.
Stefan J Schaller, MD
CONTACT
Vera Karner, MSc
CONTACT
Medical University of Vienna
Other
Early Rehabilitation of Intensive Care Unit Patients - a Multinational Prospective Observational Study on Dosage and Outcome
Acronym: ERUPT
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.
Published trials that share one or more normalized conditions with this study.
NCT07420946
Airway Clearance, Consensus
Naples, Italy
View Trial DetailsNCT07510776
Critical Care, Critical Care Medicine
Lisbon, Lisbon District, Portugal
View Trial DetailsNCT07189091
Acute Kidney Injury, Critical Care, Intensive Care
Antwerp, Belgium
View Trial DetailsNCT07687368
Continuous Glucose Monitoring, Critical Care Nursing
Barcelona, Catalonia, Spain
View Trial Details