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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intensive Care
• Intervention / Treatment: Other: blood sample and muscular biopsy

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Boris JUNG, MD,PhD; Phone Number: 00467337736; Email: b-jung@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2022
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: June 24, 2019
• First Submitted That Met QC Criteria: March 20, 2020
• First Posted (Actual): March 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 29, 2021
• Last Update Submitted That Met QC Criteria: December 28, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: Intensive Care Unit; Prolonged Stay in Intensive Care Unit
• Other Study ID Numbers: RECHMPL18_0465_7732

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: 12 months after the main publication
• IPD Sharing Access Criteria: Dataset will be shared after careful examination by the study board of investigators.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No