Prognostication of Need for Rehabilitation and Special Support in ICU Survivors (PROGRESS-ICU)
|ClinicalTrials.gov Identifier: NCT02679157|
Recruitment Status : Completed
First Posted : February 10, 2016
Last Update Posted : February 13, 2018
Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study
- To investigate associations between potential risk factors (premorbid factors, in-ICU treatments/diagnoses and patient status at ICU discharge) and three-month physical and psychological outcome in ICU survivors.
- Based on the associations between identified risk factors and adverse outcomes, create and validate instruments, to be used at ICU discharge, predicting new-onset physical or psychological problems three months after ICU discharge.
Prospective, observational multi centre (10 centres) cohort studies
Adverse psychological outcome three months after ICU discharge (Posttraumatic Stress Syndrome-14 (PTSS-14) part B score >45 or Hospital Anxiety and Depression Scale (HADS) subscale score >10). New-onset physical disability, defined as a reduction in Barthel Index ≥10 points compared with 2 weeks prior to hospital admission.
Recruitment of patients during 2-4 months in the ten study sites. Follow-up of primary endpoints 3 months after ICU discharge.
Number of subjects:
The aim is to screen all eligible patients and include 600-1000 ICU survivors during the recruitment period. The final number of included patients depends on case-mix in the units and potential exclusions.
Adult patients (18 years or older) discharged from ICU.
|Condition or disease|
|Physical Disability Depression Posttraumatic Stress Disorder Anxiety|
|Study Type :||Observational|
|Actual Enrollment :||573 participants|
|Official Title:||Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
- Adverse psychological outcome [ Time Frame: Three months post-ICU ]Caseness defined as PTSS-14 part B score above 45 or HADS subscale score above 10
- Adverse physical outcome [ Time Frame: Three months post-ICU ]Caseness defined as Reduction in Barthel Index (0-100) by 10 points or more
- Health-related quality of life assessed with Short Form -36 in patients [ Time Frame: In first three months post-ICU ]Health-related quality of Life domains in relation to adverse outcomes
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679157
|Odense University Hospital|
|University Medical Centre Radboud|
|University Medical Centre Utrecht|
|Östersund, Jämtland, Sweden|
|Umeå University Hospital|
|Umeå, Västerbotten, Sweden|
|Dept of Anesthesiology, Surgical Services and Intensive Care Medicine, Karolinska University Hospital|
|Stockholm, Sweden, 171 76|
|Stockholm South Hospital|
|Dept of Anesthesia and Intensive Care, Uppsala Akademiska|
|Örebro University Hospital|
|Study Chair:||Peter V Sackey, MD, PhD||Karolinska University Hospital|
|Principal Investigator:||Anna Milton, MD||Karolinska University Hospital|