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Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness

A Prospective Observational Study of Patients Suffering From Prolonged Critical Illness Treated by Patient Centered Multidisciplinary Teams at a Specialized Unit: Patient Characteristics, Treatment and Follow-up Results

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04247607
Acronym
CritillPro
Enrollment
250
Registered
2020-01-30
Start date
2019-12-13
Completion date
2023-12-31
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness

Keywords

persistent critical illness, chronic critical illness, prolonged intensive care, weaning from mechanical ventilation, decannulation, multidisciplinary team, intensive care rehabilitation

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.

Interventions

None listed

Sponsors

Karolinska Institutet
CollaboratorOTHER
Remeo AB
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness

Exclusion criteria

Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)

Design outcomes

Primary

MeasureTime frameDescription
Mortality during 12 months follow-up after dischargeAssessed 12 months after dischargeMortality during 12 months follow-up after discharge
Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)At admission to unitKatz ADL (scale 0-6, higher value better)
In-patient mortality and mortalityAssessed immediately after discharge from unitMortality during care at unit
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)3 months after discharge from unitEQ-5D-5L questionnaire
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)3 months after discharge from unitRAND36 (scale 0-100, higher value better) questionnaire
Change in mechanical ventilation statusAssessed at admittance and immediately after discharge from unitTime (Days) from admittance to unit until weaned from mechanical ventilation
Change in tracheostomy statusAssessed at admittance and immediately after discharge from unitTime (Days) from admittance to unit until decannulation

Secondary

MeasureTime frameDescription
Inflammatory status relative to outcomeThrough study completion, an average of 14 monthsHMGB1 and routine inflammation markers' effect on outcome measures
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).At admission to unitCPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)3 months after discharge from unitPHQ-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) questionnaire3 months after discharge from unitGAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
Frailty as assessed by the Clinical frailty scale (CFS)At admission to unitThe 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 testAt admission to unitThe 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) testAt admission to unitPerformed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
Swallowing function and possibility of oral intakeAt admission to unitUsing the Functional oral intake scale (FOIS)

Other

MeasureTime frameDescription
Antibiotic useFrom admittance until dischargeDays with antibiotic treatment during stay at unit.
Number and type of Health care Contacts after dischargeAssessed 12 months after discharge from unitNumber of Contacts with primary care, emergency room and hospital admissions after discharge
Need of support after discharge for patients discharged homeImmediately after discharge from unitFor patients discharged home, the type of homecare needed (if any)
Discharge destinationImmediately after discharge from unitThe location the patient was discharged to; home, rehabilitation unit, acute care hospital, nursing home, palliative care unit
Antibiotic use 12 months after dischargeFrom discharge until12 month thereafterNumber of infections treated with antibiotics after discharge

Countries

Sweden

Contacts

Primary ContactEva Sundman, MD, PhD
eva.sundman@remeo.se+46702086783
Backup ContactAnna Cedborg, MD, PhD
anna.cedborg@remeo.se+46709564216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026