Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

Study Overview
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Brief Summary
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Cycloergometer is a validated method for different care. This kind of device allow passive and active care for patient. The interest of cycloergometer for patient hospitalized in Intensive Care Unit for Sepsis has never been demonstrated. The main objective of this study is to determine the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy, on the ICU length in patients with septic shock The secondary objectives of this study are to assess the impact of early mobilization by cyclo-ergometer in association with standard physiotherapy on: the duration between hemodynamic stability* and the removal of sedation the duration between the removal of sedation and ICU discharge the mechanical ventilation duration (invasive and noninvasive)

Official Title
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Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock

Conditions
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Sepsis

Intervention / Treatment
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* Device: Early mobilisation with cyclo ergometer
* Other: Standard physiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient hospitalized in ICU Septic shock diagnosed more than 24 hours before inclusion Patient hemodynamically stable, before the 72th hour following the diagnosis of septic shock Mechanical ventilation by tracheal intubation Patient sedated with a RASS score inferior or equal to -2 Age ≥ 18 years BMI ≤ 40 kg / m² Informed patient having signed the consent Effective contraception in women of childbearing age (pregnancy test by B-HCG will be done; for menopausal women, a diagnosis of confirmation must be obtained). Exclusion Criteria: BMI> 40kg / m² Patient reduced by one or two lower limbs Rheumatological pathology, trauma or surgery of the lower limbs, pelvis or spine resulting of any limitations of the range of motions or strict immobilization Brain-injured patient and / or medulla injured Hemodialysis continues with a femoral catheter without possibility of changing the catheter location Moribund patient, Stop or Limitation of Active Therapeutics' decision Contraindications to standard physical therapy or the cyclo-ergometer Untreated orthopedics: deep vein thrombosis of the member concerned Dermatological: severe lesions or complex dressings in the sector concerned Patient with ExtraCorporeal Membrane Oxygenation (ECMO) Pregnant or breastfeeding women Patient participating in another trial with the same main objective

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early mobilisation with cyclo ergometer<br>Early mobilisation with cyclo ergometer in addition of Standard physiotherapy during sepsis for patient with sepsis in ICU | Device: Early mobilisation with cyclo ergometer<br>* Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit<br>Other: Standard physiotherapy<br>* Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking<br>|
| Active Comparator: Standard physiotherapy<br>Standard physiotherapy during sepsis for patient with sepsis in ICU | Other: Standard physiotherapy<br>* Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days between hemodynamic stability and ICU discharge | Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and ICU discharge | approximately 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days between hemodynamic stability and the removal of sedation | Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and the removal of sedation | From 3 to 10 days | 
| Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU | Number of days under mechanical ventilation (invasive and noninvasive, (after beginning of hospitalization for sepsis) ) during hospitalization in ICU | From 3 to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cycloergometer