Intensive CareMAORINCT04319822
Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit
A study testing blood sample and muscular biopsy in people with Intensive Care, run by University Hospital, Montpellier.
Trial summary
The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Intensive Care
- What is being tested?
- blood sample and muscular biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to 1 Jul 2024
- Phase
- Interventional
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mechanical ventilation for at least 72 hours and extra-respiratory organ failure
Who cannot join
- neurological or psychiatric deficit preventing the performance of assessment tests,
- chronic ventilation on tracheotomy, bedridden patient or moribund
Trial locations and contacts
No sites are listed yet.
About this study
The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS).
The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care.
Read more
The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score.
In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.
Read the detailed description
The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS). Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems central to explain the contrasting results of therapeutic trials in this syndrome.
Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems relevant to explain the contrasting results of therapeutic trials in this syndrome.
The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care
Patient at high risk of loss on functional autonomy, staying in the three intensive unit care participants will be recruited, if they present inclusion criteria and don't present exclusion criteria Inclusion criteria: - mechanical ventilation for at least 72 hours and extra-respiratory organ failure Exclusion criteria : neurological or psychiatric deficit preventing the performance of assessment tests, chronic ventilation on tracheotomy, bedridden patient or moribund
The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score. The secondary endpoints are survival, peripheral and respiratory muscle performance, metabolic stress testing, biologic features associated with muscle regeneration (quadriceps biopsy in resuscitation (before and after) and one at M6) , the quality of life and the path of care post-resuscitation. The statistical analysis will make it possible to describe the population according to 3 groups of the same size according to the Tertiles of the FIM to M6. The analysis will look for variables associated with belonging to the "case" group: patients with the highest disability (last testeile of the FIM score) compared to "controls": patients with a less severe disability (first two tiertiles of the score) FIM). In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.
Progress: 2 visits are planned (ICU, M6 and monthly telephone interviews). The duration of the inclusions will be 30 months and the duration of the follow-up of the patients will be 6 months.
Prospect :
- identification of physiopathological and structural factors (post-ICU trajectory) associated with recovery of functional autonomy and respiratory and peripheral muscular performance at a distance from a stay in intensive care unit
- the design of a personalized interventional study in order to improve the functional autonomy
- Conditions
- Intensive Care
- Being tested
- blood sample and muscular biopsy
- Keywords
- Intensive Care Unit, Prolonged Stay in Intensive Care Unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample and muscular biopsyOther
blood sample and muscular biopsy
| Study group | Role | What they receive |
|---|---|---|
| blood samples, muscular biopsy, and quality of life | Experimental | quality of life, blood samples, quadriceps biopsy in intensive care unit (before and after the ICU hospitalization and one at M6 Receives: Other: blood sample and muscular biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the functional autonomy of patient
The functional autonomy will be assessed by The Functional Independence Measure test (FIM score) 6 months after ICU
Measured: 6 months
Secondary outcomes (7)
Number of patient survival
Number of alive patient 180 days after stay in intensive care unit
Measured: 6 months
Performance of peripheral and respiratory muscles
Assessment of the patient deambulation assessed by a walking test
Measured: 6 months
metabolic stress testing
Assessment of the metabolic stress testing
Measured: 6 months
Description of the Characterization of satellite cells responsible for muscle regeneration
The aim is only to understand and describe the Characterization of satellite cells responsible for muscle regeneration ( PAX -7).
Measured: up to 6 months
Description of the Biochemical features of the peripheral muscles
Global physiological description of the Biochemical features of the peripheral muscles : proteolysis / proteosynthesis balance, mitochondrial fusion / fission markers, autophagy, mitophagy)
Measured: up to 6 months
Assessment of the patient Quality of life
Quality of life assessed by the validated test EQ5D
Measured: up to 6 months
Assessment of the post ICU medical care and social environement
Assessed by the validatedtest : Social Provisions Scale
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study startJan 2022 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319822
- Sponsor's protocol ID
- RECHMPL18_0465_7732
- Acronym
- MAORI
- Status last verified
- Dec 2021
- First submitted
- 24 Jun 2019
- Last updated
- 29 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04319822
- Acronym / sponsor ID
- MAORI / RECHMPL18_0465_7732
- Conditions
- Intensive Care
- Keywords
- Intensive Care Unit, Prolonged Stay in Intensive Care Unit
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 24 Mar 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.
The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS).
The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care.
The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score.
In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.
Detailed description
The hospital survival of patients hospitalized after prolonged stay in intensive care unit has improved however there are a loss of functional autonomy and an impaired of peripheral and respiratory muscle performance, what leads to an impairment life's quality. These sequels constitute the Post Intensive Care Syndrome (PICS). Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems central to explain the contrasting results of therapeutic trials in this syndrome.
Incomplete understanding of the physiopathological mechanisms that allow the recovery of functional autonomy and the lack of consideration of post-intensive care pathway seems relevant to explain the contrasting results of therapeutic trials in this syndrome.
The objective of this cohort is to describe the functional autonomy at 6 months of a prolonged stay in intensive care unit and to study the associations between functional autonomy and 1 / the biological data obtained from quadriceps biopsies / the trajectory of post-resuscitation care
Patient at high risk of loss on functional autonomy, staying in the three intensive unit care participants will be recruited, if they present inclusion criteria and don't present exclusion criteria Inclusion criteria: - mechanical ventilation for at least 72 hours and extra-respiratory organ failure Exclusion criteria : neurological or psychiatric deficit preventing the performance of assessment tests, chronic ventilation on tracheotomy, bedridden patient or moribund
The primary endpoint is functional autonomy at 6 months of ICU stay, assessed by the Functional Independence Measure (FIM) score. The secondary endpoints are survival, peripheral and respiratory muscle performance, metabolic stress testing, biologic features associated with muscle regeneration (quadriceps biopsy in resuscitation (before and after) and one at M6) , the quality of life and the path of care post-resuscitation. The statistical analysis will make it possible to describe the population according to 3 groups of the same size according to the Tertiles of the FIM to M6. The analysis will look for variables associated with belonging to the "case" group: patients with the highest disability (last testeile of the FIM score) compared to "controls": patients with a less severe disability (first two tiertiles of the score) FIM). In order to take into account a rate of loss of sight we propose to include in this cohort 120 subjects during their stay in intensive care unit.
Progress: 2 visits are planned (ICU, M6 and monthly telephone interviews). The duration of the inclusions will be 30 months and the duration of the follow-up of the patients will be 6 months.
Prospect :
- identification of physiopathological and structural factors (post-ICU trajectory) associated with recovery of functional autonomy and respiratory and peripheral muscular performance at a distance from a stay in intensive care unit
- the design of a personalized interventional study in order to improve the functional autonomy
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood samples, muscular biopsy, and quality of life | Experimental | Other: blood sample and muscular biopsyquality of life, blood samples, quadriceps biopsy in intensive care unit (before and after the ICU hospitalization and one at M6 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mechanical ventilation for at least 72 hours and extra-respiratory organ failure
Key exclusion criteria (2 listed)
- neurological or psychiatric deficit preventing the performance of assessment tests,
- chronic ventilation on tracheotomy, bedridden patient or moribund
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sample and muscular biopsyblood sample and muscular biopsy | Other | blood samples, muscular biopsy, and quality of life |
Primary outcome
Assessment of the functional autonomy of patient
Time frame: 6 months
The functional autonomy will be assessed by The Functional Independence Measure test (FIM score) 6 months after ICU
7 secondary outcomes
Number of patient survival
Time frame: 6 months
Performance of peripheral and respiratory muscles
Time frame: 6 months
metabolic stress testing
Time frame: 6 months
Description of the Characterization of satellite cells responsible for muscle regeneration
Time frame: up to 6 months
Description of the Biochemical features of the peripheral muscles
Time frame: up to 6 months
Assessment of the patient Quality of life
Time frame: up to 6 months
Assessment of the post ICU medical care and social environement
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2021.
- Individual participant dataSharing planned: Yes. Data are provided to qualified investigators free of charge. Required documents to request data include a summary of the research plan, request form, and IRB review. Dataset will be shared after careful examination by the study board of investigators.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing blood sample and muscular biopsy in people with Intensive Care, run by University Hospital, Montpellier.
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 2 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 29 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
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 Boris JUNG, MD,PhD (00467337736, b-jung@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the functional autonomy of patient (time frame: 6 months). 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 29 Dec 2021.