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

Intensive Care Clinical Trial

— MAORI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04319822
• Other study ID #: RECHMPL18_0465_7732
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2022
• Est. completion date: July 1, 2024

Study information

• Verified date: December 2021
• Source: University Hospital, Montpellier
• Contact: Boris JUNG, MD,PhD
• Phone: 00467337736
• Email: b-jung[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: July 1, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Intensive Care

Intervention

Other:
• blood sample and muscular biopsy
blood sample and muscular biopsy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	Number of patient survival	Number of alive patient 180 days after stay in intensive care unit	6 months
Secondary	Performance of peripheral and respiratory muscles	Assessment of the patient deambulation assessed by a walking test	6 months
Secondary	metabolic stress testing	Assessment of the metabolic stress testing	6 months
Secondary	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).	up to 6 months
Secondary	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)	up to 6 months
Secondary	Assessment of the patient Quality of life	Quality of life assessed by the validated test EQ5D	up to 6 months
Secondary	Assessment of the post ICU medical care and social environement	Assessed by the validatedtest : Social Provisions Scale	up to 6 months