SepsisNCT01503684
Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome
An observational study of Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Determined by intended physician
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to not given
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube.
Who may be able to join
- above 20 years old
- admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Jih-Shuin Jerng, MD, PhD, 886-2-23562905, jsjerng@ntu.edu.tw
Jih-Shuin Jerng, MD, PhD
About this study
In this proposal, the investigators wish to investigate, identify and validate potential biomarkers in collected exhaled breath condensates (EBC) from patients with sepsis.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Determined by intended physician
- Keywords
- sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determined by intended physicianOther
We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
| Study group | Role | What they receive |
|---|---|---|
| Patients with sepsis | Patients who are admitted to ICU with the diagnosis of sepsis Receives: Other: Determined by intended physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and severity of sepsis
To record APACHE II, SOFA, and MODS, etc.
Measured: 28 days
Secondary outcomes (2)
Mortality
Measured: 28 days
Response to treatment and progression of organ failure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2012 (estimated)
- Study startAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jih-Shuin Jerng, MD, PhD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01503684
- Sponsor's protocol ID
- 201106068RC
- Status last verified
- Sep 2011
- First submitted
- 2 Jan 2012
- Last updated
- 4 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Exhaled Breath Condensates of Septic Patients to Predict Development of Multi-organ Dysfunction Syndrome
- ClinicalTrials.gov ID
- NCT01503684
- Acronym / sponsor ID
- 201106068RC
- Conditions
- Sepsis
- Keywords
- sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2011
- First posted
- 4 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with sepsis | – | Other: Determined by intended physicianPatients who are admitted to ICU with the diagnosis of sepsis |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube.
Key inclusion criteria (2 listed)
- above 20 years old
- admitted to ICU with the diagnosis of sepsis and treated with mechanical ventilation via an endotracheal tube
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determined by intended physicianWe perform a prospective observational study. All the treatment for the patients are determined by intended physicians. | Other | Patients with sepsis |
Primary outcome
Development and severity of sepsis
Time frame: 28 days
To record APACHE II, SOFA, and MODS, etc.
2 secondary outcomes
Mortality
Time frame: 28 days
Response to treatment and progression of organ failure
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jih-Shuin Jerng, MD, PhD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 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 4 Jan 2012. 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 Taiwan. 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 Jih-Shuin Jerng, MD,PhD (886-2-23562905, jsjerng@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development and severity of sepsis (time frame: 28 days). 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 4 Jan 2012.