SepsisNCT02359240
HO-1 and Muscle Mitochondrial Dysfunction in Sepsis
An observational study of Sepsis and Atrophy, run by Changhai Hospital at 1 site in China.
Trial summary
The current project was designed to examine dynamic changes in muscle wasting during sepsis. Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role of HO-1 in it. Researchers interested in identifying factors involved in the pathology of muscle wasting during sepsis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- therapy according to SSC guidelines and muscle biopsy and standard surgery for femoral fracture and muscle biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Aug 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: septic patients; non septic patients with a femoral fracture,who need an fixation surgery
Who may be able to join
- sepsis, severe sepsis, septic shock
- clinical reason for fixation surgery of femoral fractures
Who cannot join
- no informed consent
- medical history of myopathy
- unintended weight loss before surgery or ICU admission
- chronic use of corticosteroids
Trial locations and contacts
1 site in 1 country.
China1 site
Anesthesiology and Intensive Care, Changhai Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: Skeletal Muscle Wasting in Patients With Sepsis
The current project was designed to examine dynamic changes in muscle wasting during sepsis. Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role of HO-1 in it. Researchers interested in identifying factors involved in the pathology of muscle wasting during sepsis.
Read the 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.
- Being tested
- therapy according to SSC guidelines and muscle biopsy, standard surgery for femoral fracture and muscle biopsy
- Medical subject headings
- Sepsis, Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapy according to SSC guidelines and muscle biopsyProcedure or surgery
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
standard surgery for femoral fracture and muscle biopsyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: therapy according to SSC guidelines and muscle biopsy | |
| 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. Receives: Procedure: standard surgery for femoral fracture and muscle biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis
Measured: 3 days after diagnosis
Secondary outcomes (3)
length of ICU stay
Measured: 60 days
length of mechanical ventilation
Measured: 60 days
muscle myosin content
Measured: 3 days after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Deng, Changhai Hospital
- Investigators
- Xiaoming Deng, M.D., Ph.D., Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359240
- Sponsor's protocol ID
- CH1502
- Status last verified
- Feb 2015
- First submitted
- 28 Jan 2015
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle Wasting in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT02359240
- Acronym / sponsor ID
- CH1502
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current project was designed to examine dynamic changes in muscle wasting during sepsis. Researchers will focus the mitochondrial dysfunction of muscle cells and investigate the role of HO-1 in it. Researchers interested in identifying factors involved in the pathology of muscle wasting during sepsis.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | Procedure: therapy according to SSC guidelines and muscle biopsyPatients 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 |
| Patients with femoral fractures | – | Procedure: standard surgery for femoral fracture and muscle biopsynon septic patients with a femoral fracture,who need an fixation surgery.standard surgery for femoral fracture and muscle biopsy will be performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- septic patients; non septic patients with a femoral fracture,who need an fixation surgery
Key inclusion criteria (2 listed)
- sepsis, severe sepsis, septic shock
- clinical reason for fixation surgery of femoral fractures
Key exclusion criteria (4 listed)
- no informed consent
- medical history of myopathy
- unintended weight loss before surgery or ICU admission
- chronic use of corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapy according to SSC guidelines and muscle biopsySeptic 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 | Procedure or surgery | sepsis |
| standard surgery for femoral fracture and muscle biopsyPatients 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 | Procedure or surgery | Patients with femoral fractures |
Primary outcome
HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis
Time frame: 3 days after diagnosis
3 secondary outcomes
length of ICU stay
Time frame: 60 days
length of mechanical ventilation
Time frame: 60 days
muscle myosin content
Time frame: 3 days after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Deng, M.D., Ph.D. principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Atrophy, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis (time frame: 3 days after diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.