AzTrials
AzTrials

Age:18-70 YearsNCT02164786

Metabolomics Dynamics Study for Severe Patient

An observational study of Age:18-70 Years and Acute Severe Disease, run by Sichuan Academy of Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
How many people
600 participants
Where
1 siteChina
Study dates
Jun 2014to Dec 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Patients suffering from acute severe disease

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting
  • Sichuan Academy of Medical Sciences

    Chengdu, Sichuan, 610072

    Hua Jiang, MBBS,PhD, 8613980001701, cdjianghua@gmail.com

    Bin Cai, MBBS, 86-18981838125, bin.cai@traumabank.org

    Recruiting

Other trials in China

About this study

Official title: 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.

Keywords
Acute severe disease, Intensive care unit, adult, cohort study, metabolomics, NMR, High Performance Liquid Chromatography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02164786
Study groupRoleWhat they receive
Acute severe diseaseNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mortality at hospitalization

    Measured: Death events from admission to discharge(up to 10 weeks)

Secondary outcomes (1)
  1. Multi Organ Dysfunction Syndrome(MODS)

    Measured: MODS events occurence from admission to discharge(up to 10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jun 2014 (estimated)
  2. Study startJun 2014
  3. Primary completionMay 2018 (estimated)
  4. Study completionDec 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02164786
Sponsor's protocol ID
MetaLab_2014_001
Status last verified
Apr 2016
First submitted
13 Jun 2014
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Age:18-70 Years and Acute Severe Disease, run by Sichuan Academy of Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hua Jiang, PhD, MBBS (86-28-88424391, hua.jiang@traumabank.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mortality at hospitalization (time frame: Death events from admission to discharge(up to 10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2017.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in