NCT02359240

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 9, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 9, 2015

Status Verified

February 1, 2015

Enrollment Period

1.5 years

First QC Date

January 28, 2015

Last Update Submit

February 4, 2015

Conditions

SepsisAtrophy

Outcome Measures

Primary Outcomes (1)

  • HO-1 mRNA and protein expression, mitochondria function of musculus vastus lateralis

    3 days after diagnosis

Secondary Outcomes (3)

  • length of ICU stay

    60 days

  • length of mechanical ventilation

    60 days

  • muscle myosin content

    3 days after diagnosis

Study Arms (2)

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

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

Interventions

therapy according to SSC guidelines and muscle biopsyPROCEDURE

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

sepsis
standard surgery for femoral fracture and muscle biopsyPROCEDURE

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

Patients with femoral fractures

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • sepsis, severe sepsis, septic shock
  • clinical reason for fixation surgery of femoral fractures

You may not qualify if:

  • no informed consent
  • medical history of myopathy
  • unintended weight loss before surgery or ICU admission
  • chronic use of corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anesthesiology and Intensive Care, Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

skeletal muscle

MeSH Terms

Conditions

SepsisAtrophy

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsPathological Conditions, Anatomical

Study Officials

  • Xiaoming Deng, M.D., Ph.D.

    Changhai Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Professer

Study Record Dates

First Submitted

January 28, 2015

First Posted

February 9, 2015

Study Start

December 1, 2014

Primary Completion

June 1, 2016

Study Completion

August 1, 2016

Last Updated

February 9, 2015

Record last verified: 2015-02

Locations

CN(1)