Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome

Sponsor

National Taiwan University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01503684

Collaborator

National Science Council, Taiwan (Other)

300

Enrollment

Location

Study Details

Study Description

Brief Summary

In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Other: Determined by intended physician

Detailed Description

In this proposed project, we will focus on the identification of potential biomarkers in EBC with ability to predict development of multi-organ failure. Currently, no tools could be used to evaluate the effect of mitochondrial dysfunction in sepsis. All the human studies discussing mitochondrial dysfunction in sepsis use tissue biopsies as study materials. Repeated tissue biopsy is invasive and not applicable. EBC could be collected non-invasively and conveniently. A study has demonstrated the use of metabolomic technologies in mitochondrial diseases. We believe that the metabolomic biomarkers of EBC could be used to demonstrate mitochondrial dysfunction in lungs and respiratory tracts of septic patients. Such metabolomic biomarkers may also reflect similar on-going mitochondrial dysfunction in other organ systems, and could potentially become a novel diagnostic tool and a therapeutic target in future sepsis therapy.

Study Design

Study Type:

Observational

Anticipated Enrollment :

300 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome

Study Start Date :

Aug 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Patients with sepsis Patients who are admitted to ICU with the diagnosis of sepsis	Other: Determined by intended physician We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.

Arm

Intervention/Treatment

Patients with sepsis

Patients who are admitted to ICU with the diagnosis of sepsis

Other: Determined by intended physician

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

Outcome Measures

Primary Outcome Measures

Development and severity of sepsis [28 days]
To record APACHE II, SOFA, and MODS, etc.

Secondary Outcome Measures

Mortality [28 days]
Response to treatment and progression of organ failure [28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

above 20 years old
admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube

Exclusion Criteria:

pregnant
active malignancy
in an immunosuppressed status such as HIV disease, neutropenia, being treated with immunosuppressive agents
expected to have an unavoidable very short life expectancy after admission, i.e., < 3 days

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Taiwan University Hospital	Taipei		Taiwan	100

Sponsors and Collaborators

National Taiwan University Hospital
National Science Council, Taiwan

Investigators

Principal Investigator: Jih-Shuin Jerng, MD, PhD, National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

National Taiwan University Hospital

ClinicalTrials.gov Identifier:

NCT01503684

Other Study ID Numbers:

201106068RC

First Posted:

Jan 4, 2012

Last Update Posted:

Jan 4, 2012

Last Verified:

Sep 1, 2011

Keywords provided by National Taiwan University Hospital

sepsis

Additional relevant MeSH terms:

Sepsis

Study Results

No Results Posted as of Jan 4, 2012