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Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit (MAORI)

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ClinicalTrials.gov Identifier: NCT04319822
Recruitment Status : Not yet recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Intensive Care Other: blood sample and muscular biopsy Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Mobility, Functional Autonomy and Respiratory Function After Prolonged Stay in Intensive Care Unit
Estimated Study Start Date : June 15, 2020
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : February 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: blood samples, muscular biopsy, and quality of life
quality of life, blood samples, quadriceps biopsy in intensive care unit (before and after the ICU hospitalization and one at M6
Other: blood sample and muscular biopsy
blood sample and muscular biopsy




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patient survival [ Time Frame: 6 months ]
    Number of alive patient 180 days after stay in intensive care unit

  2. Performance of peripheral and respiratory muscles [ Time Frame: 6 months ]
    Assessment of the patient deambulation assessed by a walking test

  3. metabolic stress testing [ Time Frame: 6 months ]
    Assessment of the metabolic stress testing

  4. Description of the Characterization of satellite cells responsible for muscle regeneration [ Time Frame: up to 6 months ]
    The aim is only to understand and describe the Characterization of satellite cells responsible for muscle regeneration ( PAX -7).

  5. Description of the Biochemical features of the peripheral muscles [ Time Frame: up to 6 months ]
    Global physiological description of the Biochemical features of the peripheral muscles : proteolysis / proteosynthesis balance, mitochondrial fusion / fission markers, autophagy, mitophagy)

  6. Assessment of the patient Quality of life [ Time Frame: up to 6 months ]
    Quality of life assessed by the validated test EQ5D

  7. Assessment of the post ICU medical care and social environement [ Time Frame: up to 6 months ]
    Assessed by the validatedtest : Social Provisions Scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319822


Contacts
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Contact: Boris JUNG, MD,PhD 00467337736 b-jung@chu-montpellier.fr

Sponsors and Collaborators
University Hospital, Montpellier
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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT04319822    
Other Study ID Numbers: RECHMPL18_0465_7732
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 12 months after the main publication
Access Criteria: Dataset will be shared after careful examination by the study board of investigators.
URL: https://biolincc.nhlbi.nih.gov/studies/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Montpellier:
Intensive Care Unit
Prolonged Stay in Intensive Care Unit