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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2023

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • Change in tracheostomy status
    • Time Frame: Assessed at admittance and immediately after discharge from unit
    • Time (Days) from admittance to unit until decannulation
  • 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: 3 months after discharge from unit
    • RAND36 (scale 0-100, higher value better) questionnaire
  • Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
    • Time Frame: 6 months after discharge from unit
    • RAND36 (scale 0-100, higher value better) questionnaire
  • 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: 3 months after discharge from unit
    • EQ-5D-5L questionnaire
  • Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
    • Time Frame: 6 months after discharge from unit
    • EQ-5D-5L 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
  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
    • Time Frame: At admission to unit
    • Katz ADL (scale 0-6, higher value better)
  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
    • Time Frame: Immediately before decannulation
    • Katz ADL (scale 0-6, higher value better)
  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
    • Time Frame: Immediately before discharge from unit
    • Katz ADL (scale 0-6, higher value better)
  • Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)
    • Time Frame: 6 months after discharge from unit
    • Katz ADL (scale 0-6, higher value better)
  • 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 Measures

  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: 3 months after discharge from unit
    • PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: 6 months after discharge from unit
    • PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms
  • Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
    • Time Frame: 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
    • Time Frame: 3 months after discharge from unit
    • GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
  • Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
    • Time Frame: 6 months after discharge
    • GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
  • Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
    • Time Frame: 12 months after discharge from unit
    • GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms
  • Frailty as assessed by the Clinical frailty scale (CFS)
    • Time Frame: At admission to unit
    • The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
  • Frailty as assessed by the Clinical frailty scale (CFS)
    • Time Frame: Immediately before discharge from unit
    • The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)
  • Frailty as assessed by the Clinical frailty scale (CFS)
    • Time Frame: At 6 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)
  • Frailty as assessed by the Clinical frailty scale (CFS)
    • Time Frame: 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
    • Time Frame: At admission to unit
    • The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
  • Physical status as assessed by the 6 minutes walk test
    • Time Frame: Immediately before decannulation
    • The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
  • Physical status as assessed by the 6 minutes walk test
    • Time Frame: Immediately before discharge from unit
    • The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
  • Physical status as assessed by the 6 minutes walk test
    • Time Frame: 6 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 6 minutes walk test
    • Time Frame: 12 months after discharge from unit
    • The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
  • Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
    • Time Frame: At admission to unit
    • Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
  • Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
    • Time Frame: Immediately before decannulation
    • Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
  • Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
    • Time Frame: Immediately before discharge from unit
    • Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
    • Time Frame: At admission to unit
    • CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
    • Time Frame: Immediately after decannulation
    • CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
    • Time Frame: Immediately before discharge from unit
    • CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
    • Time Frame: 6 months after discharge from unit
    • CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
  • Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
    • Time Frame: 12 months after discharge from unit
    • CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)
  • Swallowing function and possibility of oral intake
    • Time Frame: At admission to unit
    • Using the Functional oral intake scale (FOIS)
  • Swallowing function and possibility of oral intake
    • Time Frame: Immediately before decannulation
    • Using the Functional oral intake scale (FOIS)
  • Swallowing function and possibility of oral intake
    • Time Frame: Immediately before discharge from unit
    • Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
  • Swallowing function and possibility of oral intake
    • Time Frame: At at 6 months after discharge from unit
    • Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
  • Swallowing function and possibility of oral intake
    • Time Frame: 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
  • Inflammatory status relative to outcome
    • Time Frame: Through study completion, an average of 14 months
    • HMGB1 and routine inflammation markers’ effect on outcome measures

Participating in This Clinical Trial

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)

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Remeo AB
  • Collaborator
    • Karolinska Institutet
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Eva Sundman, MD, PhD, Principal Investigator, Remeo and Karolinska Institutet
  • Overall Contact(s)
    • Eva Sundman, MD, PhD, +46702086783, eva.sundman@remeo.se

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