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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02872792 |
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Date of registration:
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16/08/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock
MUEVELO |
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Scientific title:
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Early Mobilisation in Intensive Care Unit : Interest of Cyclo-ergometry in Patients With Septic Chock |
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Date of first enrolment:
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December 14, 2016 |
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Target sample size:
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234 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02872792 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Gaétan BEDUNEAU, MD |
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Address:
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Telephone:
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Email:
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gaetan.beduneau@chu-rouen.fr |
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Affiliation:
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Name:
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Gaétan BEDUNEAU, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Rouen University Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sepsis
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Intervention(s)
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Device: Early mobilisation with cyclo ergometer
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Other: Standard physiotherapy
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Primary Outcome(s)
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Number of days between hemodynamic stability and ICU discharge
[Time Frame: approximately 1 month]
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Secondary Outcome(s)
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Number of days under mechanical ventilation (invasive and noninvasive) during hospitalization in ICU
[Time Frame: From 3 to 10 days]
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Number of days between hemodynamic stability and the removal of sedation
[Time Frame: From 3 to 10 days]
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Secondary ID(s)
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2014/211/HP
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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