NCT01503723

Brief Summary

Metabolomics, or metabonomics, is a large-scale approach to monitoring as many as possible of the compounds involved in cellular processes in a single assay to derive metabolic profiles. Metabolomics allows for a global assessment of a cellular state within the context of the immediate environment, taking into account genetic regulation, altered kinetic activity of enzymes, and changes in metabolic reactions. Metabolomics may be useful for understanding metabolic imbalances and for diagnosis of human disease. The investigators plan to collect exhaled breath condensate from patients with acute lung injury. Metabolomic analysis in the patients may help us to explore some novel biomarkers for the disease diagnosis and outcome prediction.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 2, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
Last Updated

January 4, 2012

Status Verified

September 1, 2011

First QC Date

January 2, 2012

Last Update Submit

January 3, 2012

Conditions

Acute Lung Injury

Outcome Measures

Primary Outcomes (2)

  • Diagnosis

    To differentiate ALI/ARDS from cardiogenic pulmonary edema or other causes

    28 days

  • Disease severity

    28 days

Study Arms (1)

Patients with acute lung injury

Patients who are admitted to ICU with the diagnosis of acute hypoxemic respiratory failure

Other: Determined by intended physician

Interventions

Determined by intended physicianOTHER

We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.

Patients with acute lung injury

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are admitted to ICU with the diagnosis of acute hypoxemic respiratory failure and endotracheally intubated with mechanical ventilation.

You may qualify if:

  • above 18 years old
  • admitted to ICU with the diagnosis of acute hypoxemic respiratory failure and endotracheally intubated with mechanical ventilation.

You may not qualify if:

  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Exhaled breath condensate

MeSH Terms

Conditions

Acute Lung Injury

Condition Hierarchy (Ancestors)

Lung InjuryLung DiseasesRespiratory Tract Diseases

Study Officials

  • Lu-Cheng Kuo, MD, Master

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lu-Cheng Kuo, MD, Master

CONTACT

886-2-23562905kuolc@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2012

First Posted

January 4, 2012

Study Start

August 1, 2011

Last Updated

January 4, 2012

Record last verified: 2011-09

Locations

TW(1)