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

• Sponsor: University Hospital, Rouen (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02872792
• Collaborator: (none)
• Enrollment: 122
• Location: 1
• Arms: 2
• Actual Duration (Months): 40.2
• Patients Per Site Per Month: 3

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Device: Early mobilisation with cyclo ergometer; Other: Standard physiotherapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 122 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock
• Actual Study Start Date: Dec 14, 2016
• Actual Primary Completion Date: Apr 21, 2020
• Actual Study Completion Date: Apr 21, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early mobilisation with cyclo ergometer Early mobilisation with cyclo ergometer in addition of Standard physiotherapy during sepsis for patient with sepsis in ICU	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
Active Comparator: Standard physiotherapy Standard physiotherapy during sepsis for patient with sepsis in ICU	Other: Standard physiotherapy; Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rouen University Hospital	Rouen		France

Sponsors and Collaborators

• University Hospital, Rouen

Investigators

• Principal Investigator: Gaétan BEDUNEAU, MD, Rouen University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Rouen
• ClinicalTrials.gov Identifier: NCT02872792
• Other Study ID Numbers: 2014/211/HP
• First Posted: Aug 19, 2016
• Last Update Posted: Mar 29, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by University Hospital, Rouen: cycloergometer

Study Results

No Results Posted as of Mar 29, 2022