HEALTH CARE PROFESSIONALS

Why ERUPT?

Early mobilisation is generally recommended in recent guidelines although its evidence according to meta-analysis is weak and its realization personnel-intensive. Randomized controlled trials so far have only investigated patients who had been functionally independent before intensive care unit admission. The TEAM RCT demonstrated the importance of dosing, which will be considered in the ERUPT study design.

Study Design

Prospective, multicentre observational study.

Objectives

The main objectives of the study are:

• Assessment of the variety of different mobilisation practices worldwide.
• Analysis of the association of mobilisation dosage on patient outcomes.
• Evaluation of the association of the prehospital functional status or invasive mechanical ventilation on patient outcomes.

Study Population

We aim to recruit over 6,000 patients internationally from a minimum of 200 ICUs (including at least 30 patients each (10 functionally dependent, 10 functionally independent patients, 10 patients without invasive mechanical ventilation).

Inclusion criteria:
• Adults (≥ 18 years old) within 48 hours of ICU admission
• Expected to stay > 24 hours in the ICU

Exclusion criteria:
• Patients who receive end-of-life care at the time of screening
• Patients whose treatment plans are still under discussion and/or not all team members are committed to full active treatment
• Patients whose functional status is unlikely to be obtainable
• Patients with language barriers

Data Collection

The functional baseline will be obtained retrospectively by interviewing the responsive and oriented patient or a proxy/relatives regarding the status 2 weeks before hospital admission.
Mobilisation data (frequency, duration and level) together with organ support, interventions, sedation and basical nutritional information will be recorded daily until ICU discharge (until day 28 at the latest).
Functional tests and questionnaires will be conducted at ICU discharge and at the 90 days follow up (telephone interview).

Please find detailed information about the study assessments (obligatory and facultative data) here.

Data Management & Data Protection

Clincase (https://www.clincase.com/) by the company Quadratek will be used to provide the eCRFs. The Medical University of Vienna provides the aforementioned electronic data collection system for quality-assured documentation of multicentre studies. The system complies with the regulations of the Food and Drug Administration (FDA) – Regulation 21 CRF Part 11 and the Good Clinical Practice (GCP) criteria.

Participant confidentiality is strictly held in trust by the participating investigators and their staff. All medical or administrative staff with access to the data are subject to a duty of confidentiality and data protection. Therefore, the documentation, data and all other information generated will be held in strict confidentiality agreement protocols. 

Study Duration

Screening and recruitment: Participating ICUs will screen and collect data for all newly admitted patients with the aim of sets of 30. Per ICU a maximum of 3 complete sets (90 patients) will be allowed. 

The duration for each patient is 90 days (ICU admission – 90 days follow up). 

Total duration: Given the large number of ICUs, the total duration of the study will be 21 months.

Planned start of patient recruitment: October 2025, with protocol approval (if required by local authorities) to be obtained prior to enrolment of participants. Study centres interested in participating in the study can also join the study at a later date.

Participation

If you are interested in participation please fill in our survey.

National coordinators will support the preparation of study documents and assist you in obtaining regulatory approval from relevant ethics committees.

Authorship

We will acknowledge your collaboration in our ERUPT Study according to our publication policy. Please find details on the criteria for authorship here.

Study Documents

We are delighted to share our study protocol with you. For a sneak peek, have a look into the ERUPT synopsis. However, if you are curious and need further information about the ERUPT Study, do not hesitate to contact us.

If required we can provide drafts for Informed Consent forms, both in English and German. Consent forms are not yet examined by an ethics board, as the consent procedure at our local study site consists of an initial waiver with oral consent at follow-up (more details in the study protocol linked above).

ETHICS & Registration

The ERUPT Study was approved by the Ethics Committee of the Medical University of Vienna on 30th of April 2025 (Vote no. 1272/2025) and is registered on ClinicalTrials.gov (ID: NCT06960642).

Contract

Please find a draft of the Agreement on the conduct of our ERUPT Study here.