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

This study is currently recruiting participants.
Verified September 2011 by National Taiwan University Hospital
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01503684
First received: January 2, 2012
Last updated: January 3, 2012
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention
Sepsis
 Other: Determined by intended physician

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Development and severity of sepsis [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To record APACHE II, SOFA, and MODS, etc.


Secondary Outcome Measures:
  • Mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Response to treatment and progression of organ failure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Exhaled breath condensate


Estimated Enrollment: 300
Study Start Date: August 2011
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients who are admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503684

Contacts
Contact: Jih-Shuin Jerng, MD,PhD 886-2-23562905 jsjerng@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Jih-Shuin Jerng, MD, PhD     886-2-23562905     jsjerng@ntu.edu.tw    
Principal Investigator: Jih-Shuin Jerng, MD, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
National Science Council, Taiwan
Investigators
Principal Investigator: Jih-Shuin Jerng, MD, PhD National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01503684     History of Changes
Other Study ID Numbers: 201106068RC
Study First Received: January 2, 2012
Last Updated: January 3, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
sepsis

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013