Status:
UNKNOWN
Efficacy and Safety of a Multicomponent Physical Therapy Program in Mechanically Ventilated Patient With Sepsis
Lead Sponsor:
Zhujiang Hospital
Collaborating Sponsors:
Southern Medical University, China
Conditions:
Sepsis
Eligibility:
All Genders
16-75 years
Phase:
NA
Brief Summary
Despite of a remarkable decrease in overall mortality has been achieved following the International Guidelines for Management of Sepsis and Septic Shock since 2004,the short-and long-term outcomes rem...
Detailed Description
The study is a prospective, multi-center, assessor-blinded, randomized controlled trial and will be conducted in 9 medical ICUs at 7 tertiary hospitals in Southern China. Mechanically ventilated septi...
Eligibility Criteria
Inclusion
- Diagnosed with sepsis in accordance with the Sepsis-3 Criteria.
- 16 ≤ age ≤ 75 years.
- Mechanically ventilated for less than 72 hours at recruitment and expected to continue for at least 3 days.
- Ability to obtain informed consent from patient or proxy.
Exclusion
- acute central nervous system disease (e.g. severe cerebral injury, acute cerebral hemorrhage, brain infarction).
- active neuromuscular diseases that limiting patient to physical training (e.g. amyotrophic lateral sclerosis, multiple sclerosis, myasthenia gravis, polymyositis, muscular dystrophy).
- severe thoracic or abdominal trauma.
- acute myocardial infarction, severe arrhythmia, acute heart failure, hemo-dynamic instability or shock.
- drug abuse, alcohol addiction, opiates or other drug dependence and psychiatric disorder history.
- known pregnancy.
- malignant tumor, cachexia, end stage of chronic illness.
- contraindications to rehabilitation therapy.
- inability to obtain an informed consent from patient or a proxy.
- any other factors such as fractures or limb malformation, that would prevent response to physical exercise or cause injury to the patient.
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2021
Estimated Enrollment :
800 Patients enrolled
Trial Details
Trial ID
NCT03406494
Start Date
March 1 2018
End Date
April 30 2021
Last Update
January 23 2018
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