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

NCT02872792 | Terminated

• 1 other identifier: 2014/211/HP
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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. 1.the duration between hemodynamic stability\* and the removal of sedation
2. 2.the duration between the removal of sedation and ICU discharge
3. 3.the mechanical ventilation duration (invasive and noninvasive)

Conditions

Sepsis

Keywords

cycloergometer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of days between hemodynamic stability and the removal of sedation

  From 3 to 10 days

• Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU

  From 3 to 10 days

Study Arms (2)

Early mobilisation with cyclo ergometer

EXPERIMENTAL

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

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

Standard physiotherapy

ACTIVE COMPARATOR

Standard physiotherapy during sepsis for patient with sepsis in ICU

Other: Standard physiotherapy

Interventions

Early mobilisation with cyclo ergometer DEVICE

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

Early mobilisation with cyclo ergometer

Standard physiotherapy OTHER

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

Early mobilisation with cyclo ergometer; Standard physiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient hospitalized in ICU
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead

Study Sites (1)

Rouen University Hospital

Rouen, France

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Gaétan BEDUNEAU, MD

  University Hospital, Rouen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: August 19, 2016
• Study Start: December 14, 2016
• Primary Completion: April 21, 2020
• Study Completion: April 21, 2020
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)