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

Sepsis Clinical Trial

— MUEVELO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02872792
• Other study ID #: 2014/211/HP
• Status: Terminated
• Phase: N/A
• Start date: December 14, 2016
• Est. completion date: April 21, 2020

Study information

• Verified date: March 2022
• Source: University Hospital, Rouen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 122
• Est. completion date: April 21, 2020
• Est. primary completion date: April 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

Device:
• Early mobilisation with cyclo ergometer
Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit

Other:
• Standard physiotherapy
Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

Locations

Country	Name	City	State
France	Rouen University Hospital	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Rouen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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