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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 14, 2011

Last Updated Date

July 26, 2011

Start Date ^ICMJE

June 2010

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01279239 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Metabonomics Fingerprinting of Multiple Trauma

Official Title ^ICMJE

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

Brief 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.

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Plasma from peripheral blood.

Sampling Method

Non-Probability Sample

Study Population

Patients who are suffering from poly trauma.

Condition ^ICMJE

Trauma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT Number ^ICMJE

NCT01279239

Other Study ID Numbers ^ICMJE

META-LAB-10-07-003C-02

Has Data Monitoring Committee

Responsible Party

Hua Jiang/Deputy Chief Surgeon, Sichuan Academy of Medical Sciences, Sichuan Provincial People's Hospital

Study Sponsor ^ICMJE

Sichuan Academy of Medical Sciences

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Sichuan Academy of Medical Sciences

Verification Date

July 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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