Metabonomics Fingerprinting of Multiple Trauma

Trauma Clinical Trial

Official title:

Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01279239
• Other study ID #: META-LAB-10-07-003C-02
• Status: Completed
• Phase: N/A
• First received: January 14, 2011
• Last updated: July 26, 2011
• Start date: June 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Sichuan Academy of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The aim of this study is to establish plasma metabonomics fingerprinting atlas for severe multiple trauma patient using 1H nuclear magnetic resonance (NMR) based metabonomics methodology and advanced mathematics tools.

Description:

Metabonomics is a set of measurements of the dynamic metabolic responses of living systems to stimuli or modifications. This field of study developed from the application of nuclear magnetic resonance (NMR) spectroscopy and mass spectrometry as tools for the study of complex biofluids. Metabonomics is one of the emerging fields of systemic biology researches concerned with the high-throughput identification, quantification and characterization of small molecule metabolites. A metabonomics fingerprinting can be defined as the complete complement of all small molecule (<1500 Da) metabolites found in a specific cell, body fluid, organ or organism.

Severe poly trauma involves complex injuries that consist of multiple pathological mechanisms involving cytotoxic, oxidation stress and immune-endocrine. The complexity of the pathological physiology and biochemistry process are determined not only by the initial mechanical assault, but also by secondary processes including abnormality of inflammation regulation, ischemia, anoxia, free-radical formation, and immune dysfunction that occur over hours and days following the injury. For the clinical perspective, one of the key difficulties is to identify the most at-risk patients who could develop multiple organ failures and consequently death.

This study aims to establish the dynamics of NMR-based metabonomics fingerprinting of severe multi-trauma patients in order to provide a possible multiple organs failure (MOF) or death event prediction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Age:18-50 years

• Poly trauma

• Injury Severity Score (ISS)>16 and Acute Physiology And Chronic Health Evaluation(APACHE)II>10

Exclusion Criteria:

• With comorbidity (Diabetes,Hyperthyroidism or primary organ dysfunction )

• Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma
• Wounds and Injuries

Locations

Country	Name	City	State
China	Sichuan Academy of Medical Sciences, Sichuan Provincial Hospital, Dept. Trauma Surgery	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality at hospitalization		Death events from admission to discharge(up to 10 weeks)	No
Secondary	Multi Organ Failure(MOF)		MOF events occurence from admission to discharge(up to 10 weeks)	No