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

• Conditions: Sepsis
• Interventions: Other: Determined by intended physician

• Registration Number: NCT01503684
• Lead Sponsor: National Taiwan University Hospital

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.

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 Timeline

• Study Start: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2012-01-02
• Study First Submitted QC: 2012-01-03
• Last Update Submitted: 2012-01-03
• Study First Posted: 2012-01-04
• Last Update Posted: 2012-01-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with sepsis	Determined by intended physician	Patients who are admitted to ICU with the diagnosis of sepsis

Primary Outcome Measures

Name	Time	Method
Development and severity of sepsis	28 days	To record APACHE II, SOFA, and MODS, etc.

Secondary Outcome Measures

Name	Time	Method
Response to treatment and progression of organ failure	28 days
Mortality	28 days

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan