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

Critical Illness Clinical Trial

— CritillPro  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04247607
• Other study ID #: 2019120000
• Secondary ID: Dnr 2019-05294
• Status: Recruiting
• Start date: December 13, 2019
• Est. completion date: December 2023

Study information

• Verified date: November 2022
• Source: Remeo AB
• Contact: Eva Sundman, MD, PhD
• Phone: +46702086783
• Email: eva.sundman[@]remeo.se
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness

Locations

Country	Name	City	State
Sweden	Remeo	Sköndal	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Remeo AB	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Antibiotic use	Days with antibiotic treatment during stay at unit.	From admittance until discharge
Other	Antibiotic use 12 months after discharge	Number of infections treated with antibiotics after discharge	From discharge until12 month thereafter
Other	Discharge destination	The location the patient was discharged to; home, rehabilitation unit, acute care hospital, nursing home, palliative care unit	Immediately after discharge from unit
Other	Need of support after discharge for patients discharged home	For patients discharged home, the type of homecare needed (if any)	Immediately after discharge from unit
Other	Number and type of Health care Contacts after discharge	Number of Contacts with primary care, emergency room and hospital admissions after discharge	Assessed 12 months after discharge from unit
Primary	Change in mechanical ventilation status	Time (Days) from admittance to unit until weaned from mechanical ventilation	Assessed at admittance and immediately after discharge from unit
Primary	Change in tracheostomy status	Time (Days) from admittance to unit until decannulation	Assessed at admittance and immediately after discharge from unit
Primary	In-patient mortality and mortality	Mortality during care at unit	Assessed immediately after discharge from unit
Primary	Mortality during 12 months follow-up after discharge	Mortality during 12 months follow-up after discharge	Assessed 12 months after discharge
Primary	Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)	RAND36 (scale 0-100, higher value better) questionnaire	3 months after discharge from unit
Primary	Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)	RAND36 (scale 0-100, higher value better) questionnaire	6 months after discharge from unit
Primary	Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)	RAND36 (scale 0-100, higher value better) questionnaire	12 months after discharge from unit
Primary	Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)	EQ-5D-5L questionnaire	3 months after discharge from unit
Primary	Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)	EQ-5D-5L questionnaire	6 months after discharge from unit
Primary	Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)	EQ-5D-5L questionnaire	12 months after discharge from unit
Primary	Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)	Katz ADL (scale 0-6, higher value better)	At admission to unit
Primary	Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)	Katz ADL (scale 0-6, higher value better)	Immediately before decannulation
Primary	Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)	Katz ADL (scale 0-6, higher value better)	Immediately before discharge from unit
Primary	Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)	Katz ADL (scale 0-6, higher value better)	6 months after discharge from unit
Primary	Independence in activities of daily living assessed by Katz Index of Independence in Activities of Daily Living (Katz ADL)	Katz ADL (scale 0-6, higher value better)	12 months after discharge from unit
Secondary	Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms	3 months after discharge from unit
Secondary	Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms	6 months after discharge from unit
Secondary	Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)	PHQ-9, a patient related outcome questionnaire, scale 0-27, higher value indicating more severe symptoms	12 months after discharge from unit
Secondary	Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire	GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms	3 months after discharge from unit
Secondary	Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire	GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms	6 months after discharge
Secondary	Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire	GAD-7, a patient related outcome questionnaire, scale 0-21, higher value indicating more severe symptoms	12 months after discharge from unit
Secondary	Frailty as assessed by the Clinical frailty scale (CFS)	The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)	At admission to unit
Secondary	Frailty as assessed by the Clinical frailty scale (CFS)	The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)	Immediately before discharge from unit
Secondary	Frailty as assessed by the Clinical frailty scale (CFS)	The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)	At 6 months after discharge from unit
Secondary	Frailty as assessed by the Clinical frailty scale (CFS)	The Clinical frailty scale has 9 levels from very fit to terminally ill (1-9, lower value indicate better outcome)	At 12 months after discharge from unit
Secondary	Physical status as assessed by the 6 minutes walk test	The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)	At admission to unit
Secondary	Physical status as assessed by the 6 minutes walk test	The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)	Immediately before decannulation
Secondary	Physical status as assessed by the 6 minutes walk test	The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)	Immediately before discharge from unit
Secondary	Physical status as assessed by the 6 minutes walk test	The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)	6 months after discharge from unit
Secondary	Physical status as assessed by the 6 minutes walk test	The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)	12 months after discharge from unit
Secondary	Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test	Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome	At admission to unit
Secondary	Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test	Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome	Immediately before decannulation
Secondary	Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test	Performed by an occupational therapist. The MoCa test score scale is 0-30 Points, higher value indicate better outcome	Immediately before discharge from unit
Secondary	Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).	CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)	At admission to unit
Secondary	Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).	CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)	Immediately after decannulation
Secondary	Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).	CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)	Immediately before discharge from unit
Secondary	Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).	CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)	6 months after discharge from unit
Secondary	Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).	CPAx performed by a physiotherapist (scale 0-50 Points, higher value indicate better outcome)	12 months after discharge from unit
Secondary	Swallowing function and possibility of oral intake	Using the Functional oral intake scale (FOIS)	At admission to unit
Secondary	Swallowing function and possibility of oral intake	Using the Functional oral intake scale (FOIS)	Immediately before decannulation
Secondary	Swallowing function and possibility of oral intake	Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function	Immediately before discharge from unit
Secondary	Swallowing function and possibility of oral intake	Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function	At at 6 months after discharge from unit
Secondary	Swallowing function and possibility of oral intake	Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function	At at 12 months after discharge from unit
Secondary	Inflammatory status relative to outcome	HMGB1 and routine inflammation markers' effect on outcome measures	Through study completion, an average of 14 months