Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Metabonomics Fingerprinting of Multiple Trauma

This study has been completed.
Sponsor:
Information provided by:
Sichuan Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01279239
First received: January 14, 2011
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.


Condition
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishing 1H Nuclear Magnetic Resonance (NMR) Based Metabonomics Fingerprinting Profile for Severe Poly Trauma Patients

Resource links provided by NLM:


Further study details as provided by Sichuan Academy of Medical Sciences:

Primary Outcome Measures:
  • Mortality at hospitalization [ Time Frame: Death events from admission to discharge(up to 10 weeks) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Multi Organ Failure(MOF) [ Time Frame: MOF events occurence from admission to discharge(up to 10 weeks) ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma from peripheral blood.


Enrollment: 40
Study Start Date: June 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Poly trauma
20 Patients suffering from poly trauma who meet inclusion criteria would be recruited
Healthy control
20 healthy volunteers would be recruited to obtain basal metabonomics fingerprinting

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients who are suffering from poly trauma.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01279239

Locations
China, Sichuan
Sichuan Academy of Medical Sciences, Sichuan Provincial Hospital, Dept. Trauma Surgery
Chengdu, Sichuan, China, 610101
Sponsors and Collaborators
Sichuan Academy of Medical Sciences
Investigators
Study Chair: Hua Jiang, M.D Sichuan Academy of Medical Sciences
Principal Investigator: Zhi-Yuan Zhou, M.S Sichuan Academy of Medical Sciences
Principal Investigator: Ming-Wei Sun, M.D Sichuan Academy of Medical Sciences
  More Information

No publications provided

Responsible Party: Hua Jiang/Deputy Chief Surgeon, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital
ClinicalTrials.gov Identifier: NCT01279239     History of Changes
Other Study ID Numbers: META-LAB-10-07-003C-02
Study First Received: January 14, 2011
Last Updated: July 26, 2011
Health Authority: China: Ministry of Health

Keywords provided by Sichuan Academy of Medical Sciences:
Poly Trauma
Metabonomics
NMR
MOF

Additional relevant MeSH terms:
Wounds and Injuries

ClinicalTrials.gov processed this record on November 25, 2014