HO-1 and Muscle Mitochondrial Dysfunction in Sepsis

Sepsis Clinical Trial

Official title:

Skeletal Muscle Wasting in Patients With Sepsis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02359240
• Other study ID #: CH1502
• Status: Active, not recruiting
• Phase: N/A
• First received: January 28, 2015
• Last updated: February 4, 2015
• Start date: December 2014
• Est. completion date: August 2016

Study information

• Verified date: February 2015
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: August 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrophy
• Sepsis

Intervention

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
• 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

Locations

Country	Name	City	State
China	Anesthesiology and Intensive Care, Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis		3 days after diagnosis	No
Secondary	length of ICU stay		60 days	No
Secondary	length of mechanical ventilation		60 days	No
Secondary	muscle myosin content		3 days after diagnosis	No