HO-1 and Muscle Mitochondrial Dysfunction in Sepsis

Sponsor
Changhai Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02359240
Collaborator
(none)
50
1
20
2.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: therapy according to SSC guidelines and muscle biopsy
  • Procedure: standard surgery for femoral fracture and muscle biopsy

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

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Skeletal Muscle Wasting in Patients With Sepsis
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm 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

Procedure: therapy according to SSC guidelines and muscle biopsy
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.

Procedure: standard surgery for femoral fracture and muscle biopsy
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

Outcome Measures

Primary Outcome Measures

  1. HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis [3 days after diagnosis]

Secondary Outcome Measures

  1. length of ICU stay [60 days]

  2. length of mechanical ventilation [60 days]

  3. muscle myosin content [3 days after diagnosis]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Anesthesiology and Intensive Care, Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

  • Principal Investigator: Xiaoming Deng, M.D., Ph.D., Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xiaoming Deng, Chief, Professer, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT02359240
Other Study ID Numbers:
  • CH1502
First Posted:
Feb 9, 2015
Last Update Posted:
Feb 9, 2015
Last Verified:
Feb 1, 2015
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2015