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

University Hospital, Rouen

Status: Terminated

Conditions: Sepsis

Treatments: Device: Early mobilisation with cyclo ergometer; Other: Standard physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02872792

2014/211/HP

Details and patient eligibility

About

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)

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Early mobilisation with cyclo ergometer

Experimental group

Description:

Early mobilisation with cyclo ergometer in addition of Standard physiotherapy during sepsis for patient with sepsis in ICU

Treatment:

Device: Early mobilisation with cyclo ergometer

Other: Standard physiotherapy

Standard physiotherapy

Active Comparator group

Description:

Standard physiotherapy during sepsis for patient with sepsis in ICU

Treatment:

Other: Standard physiotherapy