Overview

This trial is active, not recruiting.

Conditions sepsis, atrophy
Treatments therapy according to ssc guidelines and muscle biopsy, standard surgery for femoral fracture and muscle biopsy
Sponsor Changhai Hospital
Start date December 2014
End date June 2016
Trial size 50 participants
Trial identifier NCT02359240, CH1502

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
Arm
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
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
non septic patients with a femoral fracture,who need an fixation surgery.standard surgery for femoral fracture and muscle biopsy will be performed.
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

Primary Outcomes

Measure
HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis
time frame: 3 days after diagnosis

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

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

Additional Information

Official title Skeletal Muscle Wasting in Patients With Sepsis
Principal investigator Xiaoming Deng, M.D., Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2015.
Information provided to ClinicalTrials.gov by Changhai Hospital.