Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness
- Conditions
- Critical Illness
- Registration Number
- NCT04247607
- Lead Sponsor
- Remeo AB
- Brief Summary
This prospective observational study aims to describe the outcome for patients with persistent or chronic critical illness treated at Remeo, a clinic specialized for patients in need of prolonged intensive care and intensive care rehabilitation in Sweden. Patients' disease characteristics and the treatment in multidisciplinary patient centered teams for intensive care, weaning from mechanical ventilation and simultaneous rehabilitation will be described. Patients will be followed one year after discharge to document health related quality of life, physical function, frailty, mental illness and used health care resources.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness
Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in mechanical ventilation status Assessed at admittance and immediately after discharge from unit Time (Days) from admittance to unit until weaned from mechanical ventilation
In-patient mortality and mortality Assessed immediately after discharge from unit Mortality during care at unit
Mortality during 12 months follow-up after discharge Assessed 12 months after discharge Mortality during 12 months follow-up after discharge
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36) 12 months after discharge from unit RAND36 (scale 0-100, higher value better) questionnaire
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L) 12 months after discharge from unit EQ-5D-5L questionnaire
Change in tracheostomy status Assessed at admittance and immediately after discharge from unit Time (Days) from admittance to unit until decannulation
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL) 12 months after discharge from unit Katz ADL (scale 0-6, higher value better)
- Secondary Outcome Measures
Name Time Method Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9) 12 months after discharge from unit PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire 12 months after discharge from unit GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
Swallowing function and possibility of oral intake At at 12 months after discharge from unit Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Frailty as assessed by the Clinical frailty scale (CFS) At 12 months after discharge from unit The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
Physical status as assessed by the 6 minutes walk test 12 months after discharge from unit The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx). 12 months after discharge from unit CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test Immediately before discharge from unit Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
Inflammatory status relative to outcome Through study completion, an average of 14 months HMGB1 and routine inflammation markers' effect on outcome measures
Trial Locations
- Locations (1)
Remeo
🇸🇪Sköndal, Stockholm, Sweden