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Clinical Trials/NCT04247607
NCT04247607
Recruiting
Not Applicable

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

Remeo AB1 site in 1 country250 target enrollmentDecember 13, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Critical Illness
Sponsor
Remeo AB
Enrollment
250
Locations
1
Primary Endpoint
Change in mechanical ventilation status
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 13, 2019
End Date
December 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Remeo AB
Responsible Party
Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change in mechanical ventilation status

Time Frame: 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

Time Frame: Assessed immediately after discharge from unit

Mortality during care at unit

Mortality during 12 months follow-up after discharge

Time Frame: 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)

Time Frame: 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)

Time Frame: 12 months after discharge from unit

EQ-5D-5L questionnaire

Change in tracheostomy status

Time Frame: 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)

Time Frame: 12 months after discharge from unit

Katz ADL (scale 0-6, higher value better)

Secondary Outcomes

  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)(12 months after discharge from unit)
  • Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire(12 months after discharge from unit)
  • Swallowing function and possibility of oral intake(At at 12 months after discharge from unit)
  • Frailty as assessed by the Clinical frailty scale (CFS)(At 12 months after discharge from unit)
  • Physical status as assessed by the 6 minutes walk test(12 months after discharge from unit)
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).(12 months after discharge from unit)
  • Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test(Immediately before discharge from unit)
  • Inflammatory status relative to outcome(Through study completion, an average of 14 months)

Study Sites (1)

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