Clinical trial NCT02872792: Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock
Official title: Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sepsis
Keywords: cycloergometer
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-08-19
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


Eligibility criteria: 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

Primary outcomes:
measure: Number of days between hemodynamic stability and ICU discharge
timeFrame: approximately 1 month
Secondary outcomes:
measure: Number of days between hemodynamic stability and the removal of sedation
timeFrame: From 3 to 10 days
measure: Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU
timeFrame: From 3 to 10 days
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Gaétan BEDUNEAU, MD
role: PRINCIPAL_INVESTIGATOR
References: