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

NCT04319822 | Unknown

• 1 other identifier: RECHMPL18_0465_7732
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intensive Care

Keywords

Intensive Care Unit; Prolonged Stay in Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of patient survival

  6 months

• Performance of peripheral and respiratory muscles

  6 months

• metabolic stress testing

  6 months

• Description of the Characterization of satellite cells responsible for muscle regeneration

  up to 6 months

• Description of the Biochemical features of the peripheral muscles

  up to 6 months

Study Arms (1)

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

Other: blood sample and muscular biopsy

Interventions

blood sample and muscular biopsy OTHER

blood sample and muscular biopsy

blood samples, muscular biopsy, and quality of life

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mechanical ventilation for at least 72 hours and extra-respiratory organ failure

You may not qualify if:

• neurological or psychiatric deficit preventing the performance of assessment tests,
• chronic ventilation on tracheotomy, bedridden patient or moribund

Sponsors & Collaborators

• University Hospital, Montpellier: lead

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Boris JUNG, MD,PhD

CONTACT

00467337736; b-jung@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2019
• First Posted: March 24, 2020
• Study Start: January 1, 2022
• Primary Completion: April 1, 2024
• Study Completion: July 1, 2024
• Last Updated: December 29, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 12 months after the main publication
• Access Criteria: Dataset will be shared after careful examination by the study board of investigators.