CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 573 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02679157
NCT02679157N/ACompleted

Prognostication of Need for Rehabilitation and Special Support in ICU Survivors. Two Studies Prognosticating Adverse Physical or Psychological Outcome

Karolinska University Hospital·observational·Posted Feb 10, 2016·Updated Feb 13, 2018

In Brief

An observational study for Physical Disability and 3 related conditions. Completed, enrolled 573 participants across 10 sites in 3 countries.

Detailed Summary

Title: PROGnostication of need for REhabilitation and Special Support after Intensive Care Unit Stay - a multinational, observational study Objectives: 1. 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. 2. 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. Study design: Prospective, observational multi centre (10 centres) cohort studies Outcomes: 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. Study duration: 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. Population: Adult patients (18 years or older) discharged from ICU.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesDenmark, Netherlands, Sweden
CollaboratorsRegion Stockholm

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 10, 2016
Enrollment StartJan 1, 2016
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 10.4 years ago