Metabolomics Dynamics Study for Severe Patient

Modeling Metabolomic Dynamics Based on Nuclear Magnetic Resonance and High Performance Liquid Chromatography for Severe Patient: a Cohort Study

Acute severe disease is a major public health challenge that often affects young adults.In past decade, there are lot of new techniques have been developed that aim to improve the outcome of acute severe disease, But few of these works success. According to recently studies, the mortality of the multiple organ dysfunction syndrome（MODS) that is the major cause of death in patients who suffering from acute severe disease, is not improved. On the contrary, if MODS be predicted in early stage of acute severe disease, the death can be prevented. Because acute severe disease poses complex injury that involves multiple pathological processes, understanding the cellular and metabolic network malfunction during acute severe disease is crucial for clinical monitoring and intervention.

Human metabolism is a complex network with hundreds of cross-linked paths. During critical illness, the metabolic network is dynamically disturbed at multiple points. Classical research typically isolates a small part of this network to investigate the impact of pathological physiology molecular mechanisms on clinical outcome. In particular, researchers have examined metabolic disturbances such as cytokine network dysfunction, skeletal muscle breakdown, insulin resistance, dyslipidemia, testosterone and growth hormone/Insulin like growth factor （IGF）dysfunctions, low thyroxine syndrome, and deficiency of vitamin D and calcium with secondary hyperparathyroidism. These complex metabolic disturbances appear and interact at different stages during the pathological process after acute severe illness. Therefore, an integrated approach that combines the biochemical/molecular changes with network disturbances is the key to understanding acute severe illness at the systems biology level and establishing an accurate quantitative model for clinical monitoring.

An interdisciplinary method that includes high-throughput quantitative techniques and effective mathematical and visualization tools is necessary. Furthermore, interdisciplinary methods present the opportunity to develop innovative clinical diagnosis and monitoring methods for severe injuries. The aim of this study is to provide a novel high-throughput method that integrated proton-nuclear magnetic resonance (NMR) metabolomic fingerprinting and High Performance Liquid Chromatography with advance mathematics tools to modeling metabolic dynamics after acute severe disease.

Study Overview

• Status: Unknown
• Conditions: Age:18-70 Years; Acute Severe Disease; Acute Physiology And Chronic Health Evaluation(APACHE)II>10

• Study Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610072
      • Recruiting
      • Sichuan Academy of Medical Sciences
      • Contact: Hua Jiang, MBBS,PhD; Phone Number: 8613980001701; Email: cdjianghua@gmail.com
      • Contact: Bin Cai, MBBS; Phone Number: 86-18981838125; Email: bin.cai@traumabank.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from acute severe disease

Description

Inclusion Criteria:

• Age:18-70 years
• Acute Physiology And Chronic Health Evaluation(APACHE)II>10

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Acute severe disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mortality at hospitalization	Death events from admission to discharge(up to 10 weeks)

Secondary Outcome Measures

Outcome Measure	Time Frame
Multi Organ Dysfunction Syndrome(MODS)	MODS events occurence from admission to discharge(up to 10 weeks)

Collaborators and Investigators

• Sponsor: Sichuan Academy of Medical Sciences
• Investigators: Study Chair: Hua Jiang, PhD, MBBS, Sichuan Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: June 13, 2014
• First Submitted That Met QC Criteria: June 16, 2014
• First Posted (Estimate): June 17, 2014

Study Record Updates

• Last Update Posted (Actual): April 28, 2017
• Last Update Submitted That Met QC Criteria: April 26, 2017
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: adult; Intensive care unit; cohort study; NMR; metabolomics; Acute severe disease; High Performance Liquid Chromatography
• Other Study ID Numbers: MetaLab_2014_001