Critical IllnessCritillProNCT04247607
Specialized Treatment, Rehabilitation and Outcome in Patients With Prolonged Critical Illness
An observational study of Critical Illness, run by Remeo AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Critical Illness
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 13 Dec 2019to Dec 2023
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with prolonged critical illness treated at the specialized unit (Remeo, Stockholm, Sweden)
Who may be able to join
- Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness
Who cannot join
- Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Remeo
Sköndal, Stockholm County, 12864
Eva Sundman, MD, PhD, +46702086783, eva.sundman@remeo.se
Anna Cedborg, MD, PhD, +46709564216, anna.cedborg@remeo.se
About this study
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
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.
- Conditions
- Critical Illness
- Keywords
- persistent critical illness, chronic critical illness, prolonged intensive care, weaning from mechanical ventilation, decannulation, multidisciplinary team, intensive care rehabilitation
- Medical subject headings
- Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in mechanical ventilation status
Time (Days) from admittance to unit until weaned from mechanical ventilation
Measured: Assessed at admittance and immediately after discharge from unit
Change in tracheostomy status
Time (Days) from admittance to unit until decannulation
Measured: Assessed at admittance and immediately after discharge from unit
In-patient mortality and mortality
Mortality during care at unit
Measured: Assessed immediately after discharge from unit
Mortality during 12 months follow-up after discharge
Mortality during 12 months follow-up after discharge
Measured: Assessed 12 months after discharge
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
RAND36 (scale 0-100, higher value better) questionnaire
Measured: 3 months after discharge from unit
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
RAND36 (scale 0-100, higher value better) questionnaire
Measured: 6 months after discharge from unit
Health related quality of Life assessed by the Rand 36-Item Health Survey (RAND36)
RAND36 (scale 0-100, higher value better) questionnaire
Measured: 12 months after discharge from unit
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
EQ-5D-5L questionnaire
Measured: 3 months after discharge from unit
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
EQ-5D-5L questionnaire
Measured: 6 months after discharge from unit
Health related quality of Life assessed by EuroQoL 5-dimension 5-level (EQ-5D-5L)
EQ-5D-5L questionnaire
Measured: 12 months after discharge from unit
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)
Measured: At admission to unit
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)
Measured: Immediately before decannulation
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)
Measured: Immediately before discharge from unit
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)
Measured: 6 months after discharge from unit
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)
Measured: 12 months after discharge from unit
Secondary outcomes (29)
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
Measured: 3 months after discharge from unit
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
Measured: 6 months after discharge from unit
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
Measured: 12 months after discharge from unit
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
Measured: 3 months after discharge from unit
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
Measured: 6 months after discharge
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
Measured: 12 months after discharge from unit
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)
Measured: At admission to unit
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)
Measured: Immediately before discharge from unit
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)
Measured: At 6 months after discharge from unit
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)
Measured: At 12 months after discharge from unit
Physical status as assessed by the 6 minutes walk test
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Measured: At admission to unit
Physical status as assessed by the 6 minutes walk test
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Measured: Immediately before decannulation
Physical status as assessed by the 6 minutes walk test
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Measured: Immediately before discharge from unit
Physical status as assessed by the 6 minutes walk test
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Measured: 6 months after discharge from unit
Physical status as assessed by the 6 minutes walk test
The 6 min walk test evaluated by a physiotherapist (longer distance (meters) better outcome)
Measured: 12 months after discharge from unit
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
Measured: At admission to unit
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
Measured: Immediately before decannulation
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
Measured: Immediately before discharge from unit
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)
Measured: At admission to unit
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)
Measured: Immediately after decannulation
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)
Measured: Immediately before discharge from unit
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)
Measured: 6 months after discharge from unit
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)
Measured: 12 months after discharge from unit
Swallowing function and possibility of oral intake
Using the Functional oral intake scale (FOIS)
Measured: At admission to unit
Swallowing function and possibility of oral intake
Using the Functional oral intake scale (FOIS)
Measured: Immediately before decannulation
Swallowing function and possibility of oral intake
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Measured: Immediately before discharge from unit
Swallowing function and possibility of oral intake
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Measured: At at 6 months after discharge from unit
Swallowing function and possibility of oral intake
Using the Functional oral intake scale (FOIS), seven different levels 1-7, higher level indicate better function
Measured: At at 12 months after discharge from unit
Inflammatory status relative to outcome
HMGB1 and routine inflammation markers' effect on outcome measures
Measured: Through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2020
- Study start13 Dec 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Remeo AB
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet
- Responsible party
- Sponsor
- Investigators
- Eva Sundman, MD, PhD, Principal investigator, Remeo and Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04247607
- Sponsor's protocol ID
- 2019120000
- Other IDs
- Dnr 2019-05294
- Acronym
- CritillPro
- Status last verified
- Nov 2022
- First submitted
- 2 Jan 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04247607
- Acronym / sponsor ID
- CritillPro / 2019120000
- Conditions
- Critical Illness
- Keywords
- persistent critical illness, chronic critical illness, prolonged intensive care, weaning from mechanical ventilation, decannulation, multidisciplinary team, intensive care rehabilitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Remeo ABUniversity, hospital or other
- Collaborators
- Karolinska Institutet
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with prolonged critical illness treated at the specialized unit (Remeo, Stockholm, Sweden)
Key inclusion criteria (1 listed)
- Admission to unit (Remeo, Stockholm, Sweden) Treated for prolonged critical illness
Key exclusion criteria (1 listed)
- Treated less than 48 hours at unit (Remeo, Stockholm, Sweden)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
29 secondary outcomes
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months after discharge from unit
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 months after discharge from unit
Symptoms of depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months after discharge from unit
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
Time frame: 3 months after discharge from unit
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
Time frame: 6 months after discharge
Symptoms of generalized anxiety as assessed by the General anxiety disorder 7 (GAD-7) questionnaire
Time frame: 12 months after discharge from unit
Frailty as assessed by the Clinical frailty scale (CFS)
Time frame: At admission to unit
Frailty as assessed by the Clinical frailty scale (CFS)
Time frame: Immediately before discharge from unit
Frailty as assessed by the Clinical frailty scale (CFS)
Time frame: At 6 months after discharge from unit
Frailty as assessed by the Clinical frailty scale (CFS)
Time frame: At 12 months after discharge from unit
Physical status as assessed by the 6 minutes walk test
Time frame: At admission to unit
Physical status as assessed by the 6 minutes walk test
Time frame: Immediately before decannulation
Physical status as assessed by the 6 minutes walk test
Time frame: Immediately before discharge from unit
Physical status as assessed by the 6 minutes walk test
Time frame: 6 months after discharge from unit
Physical status as assessed by the 6 minutes walk test
Time frame: 12 months after discharge from unit
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
Time frame: At admission to unit
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
Time frame: Immediately before decannulation
Cognitive status as assessed by the Montreal cognitive assessment (MoCa) test
Time frame: Immediately before discharge from unit
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
Time frame: At admission to unit
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
Time frame: Immediately after decannulation
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
Time frame: Immediately before discharge from unit
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
Time frame: 6 months after discharge from unit
Physical status as assessed by the Chelsea Critical Care Physical Assessment tool (CPAx).
Time frame: 12 months after discharge from unit
Swallowing function and possibility of oral intake
Time frame: At admission to unit
Swallowing function and possibility of oral intake
Time frame: Immediately before decannulation
Swallowing function and possibility of oral intake
Time frame: Immediately before discharge from unit
Swallowing function and possibility of oral intake
Time frame: At at 6 months after discharge from unit
Swallowing function and possibility of oral intake
Time frame: At at 12 months after discharge from unit
Inflammatory status relative to outcome
Time frame: Through study completion, an average of 14 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva Sundman, MD, PhD principal investigator
Remeo and Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness, run by Remeo AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eva Sundman, MD, PhD (+46702086783, eva.sundman@remeo.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mechanical ventilation status (time frame: Assessed at admittance and immediately after discharge from unit). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.