HO-1 and Muscle Mitochondrial Dysfunction in Sepsis

February 4, 2015 updated by: Xiaoming Deng, Changhai Hospital

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.

Study Overview

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

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Anesthesiology and Intensive Care, Changhai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

septic patients; non septic patients with a femoral fracture,who need an fixation surgery

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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
3 days after diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
length of ICU stay
Time Frame: 60 days
60 days
length of mechanical ventilation
Time Frame: 60 days
60 days
muscle myosin content
Time Frame: 3 days after diagnosis
3 days after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

January 28, 2015

First Submitted That Met QC Criteria

February 4, 2015

First Posted (Estimate)

February 9, 2015

Study Record Updates

Last Update Posted (Estimate)

February 9, 2015

Last Update Submitted That Met QC Criteria

February 4, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

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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