- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02359240
HO-1 and Muscle Mitochondrial Dysfunction in Sepsis
Skeletal Muscle Wasting in Patients With Sepsis
Study Overview
Status
Detailed Description
Rapid muscle atrophy or muscle wasting occured to septic patients.Sepsis induced muscle wasting has become a severe, frequent, and persistent complication among critically ill patients. Multiple factors including ubiquitin-proteasome system, proinflammatory cytokines and oxidative stress contribute muscle proteolysis.
It is known that heme oxygenase-1 (HO-1) possesses a variety of functions like anti-inflammatory, antioxidative and anti-apoptosis effects. In order to investigate the mechanisms under the condition, researchers are going to examine the role of HO-1 in muscle atrophy during sepsis.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Shanghai
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Shanghai, Shanghai, China, 200433
- Anesthesiology and Intensive Care, Changhai Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- sepsis, severe sepsis, septic shock
- clinical reason for fixation surgery of femoral fractures
Exclusion Criteria:
- no informed consent
- medical history of myopathy
- unintended weight loss before surgery or ICU admission
- chronic use of corticosteroids
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
sepsis
Patients with a diagnosis of sepsis or severe sepsis,immobilization for 3 days at least.
Therapy according to the SSC guidelines will be applied.
therapy according to SSC guidelines and muscle biopsy
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Septic patients will be treated according to the international guidelines for management of severe sepsis and septic shock 2012.
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing.150-300
mg muscle (wet weight) was routinely obtained , which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research.
Muscle will be processed either for isolation of mRNA/microRNA or protein
|
|
Patients with femoral fractures
non septic patients with a femoral fracture,who need an fixation surgery.standard
surgery for femoral fracture and muscle biopsy will be performed.
|
Patients with femoral fracture will under standard surgery for fracture fixation.
Percutaneous needle muscle biopsies will be performed.
Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing.150-300
mg muscle (wet weight) was routinely obtained , which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research.
Muscle will be processed either for isolation of mRNA/microRNA or protein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis
Time Frame: 3 days after diagnosis
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3 days after diagnosis
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
length of ICU stay
Time Frame: 60 days
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60 days
|
|
length of mechanical ventilation
Time Frame: 60 days
|
60 days
|
|
muscle myosin content
Time Frame: 3 days after diagnosis
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3 days after diagnosis
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Xiaoming Deng, M.D., Ph.D., Changhai Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CH1502
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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