Sepsis
Conditions
Keywords
cycloergometer
Brief summary
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: 1. the duration between hemodynamic stability\* and the removal of sedation 2. the duration between the removal of sedation and ICU discharge 3. the mechanical ventilation duration (invasive and noninvasive)
Interventions
DEVICEEarly mobilisation with cyclo ergometer
Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit
OTHERStandard physiotherapy
Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking
Sponsors
University Hospital, Rouen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days between hemodynamic stability and ICU discharge | approximately 1 month | Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and ICU discharge |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of days between hemodynamic stability and the removal of sedation | From 3 to 10 days | Number of days between hemodynamic stability (after beginning of hospitalization for sepsis) and the removal of sedation |
| Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU | From 3 to 10 days | Number of days under mechanical ventilation (invasive and noninvasive, (after beginning of hospitalization for sepsis) ) during hospitalization in ICU |
Countries
France
Outcome results
None listed