Acute Respiratory Distress SyndromeNCT00557414
Serial Changes of Soluble Triggering Receptor Expressed on Myeloid Cells-1 (sTREM-1) Levels in Patients With Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory distress syndrome (ARDS) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- How many people
- 63 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2007to Mar 2008
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients admitted into ICU of a medical center in Taiwan
Who may be able to join
- Fulfill clinical diagnosis of ARDS
- Require mechanical ventilation support
Who cannot join
- Pregnant
- Immunocompromised
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Serial Changes of sTREM-1 Levels in Patients With Acute Respiratory Distress Syndrome
The purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory distress syndrome (ARDS)
Read the detailed description
The triggering receptor expressed on myeloid cells-1 (TREM-1), a member of the immunoglobulin superfamily, is upregulated on phagocytic cells in the presence of bacteria or fungi infection and weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form (sTREM-1) in body fluids. The level and serial change of a serum sTREM-1 from cirtical ill patients has been shown to be a good diagnostic and prognostic indicator of ventilation associated pneumonia (VAP) and severe sepsis.
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress syndrome, soluble triggering receptor expressed on myeloid cells-1, prognosis
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
all cause mortality
Measured: 28 days
Septic or non-septic etiology
Measured: At enrollment
Secondary outcomes (2)
CRP, lactate, WBC count, APACHE II score, LIS, SOFA score
Measured: At enrollment
IL-1 beta, IL-8, TNF-alpha
Measured: serial follow up at Day 1, 3, 5, 7, 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startOct 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies 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
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chao-Chi Ho, Principal investigator, Department of Internal Medicine and Emergency Medicine, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557414
- Sponsor's protocol ID
- 200709060R
- Status last verified
- May 2008
- First submitted
- 12 Nov 2007
- Last updated
- 13 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serial Changes of sTREM-1 Levels in Patients With Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00557414
- Acronym / sponsor ID
- 200709060R
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- acute respiratory distress syndrome, soluble triggering receptor expressed on myeloid cells-1, prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Study completion
- Mar 2008 (actual)
- First posted
- 14 Nov 2007 (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.
The purpose of this study is to determine the impact of the serum soluble triggering receptor expressed on myeloid cells-1 (sTREM-1) on etiology and prognosis of acute respiratory distress syndrome (ARDS)
Detailed description
The triggering receptor expressed on myeloid cells-1 (TREM-1), a member of the immunoglobulin superfamily, is upregulated on phagocytic cells in the presence of bacteria or fungi infection and weakly expressed in samples from patients with noninfectious inflammatory disorders. In addition, TREM-1 is shed from the membrane of activated phagocytes and can be found in a soluble form (sTREM-1) in body fluids. The level and serial change of a serum sTREM-1 from cirtical ill patients has been shown to be a good diagnostic and prognostic indicator of ventilation associated pneumonia (VAP) and severe sepsis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients admitted into ICU of a medical center in Taiwan
Key inclusion criteria (2 listed)
- Fulfill clinical diagnosis of ARDS
- Require mechanical ventilation support
Key exclusion criteria (2 listed)
- Pregnant
- Immunocompromised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
all cause mortality
Time frame: 28 days
Septic or non-septic etiology
Time frame: At enrollment
2 secondary outcomes
CRP, lactate, WBC count, APACHE II score, LIS, SOFA score
Time frame: At enrollment
IL-1 beta, IL-8, TNF-alpha
Time frame: serial follow up at Day 1, 3, 5, 7, 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2008.
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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.
Chao-Chi Ho principal investigator
Department of Internal Medicine and Emergency Medicine, 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 Acute Respiratory Distress Syndrome, 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 2 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: finished, as of the sponsor's last update on 13 May 2008. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all cause mortality (time frame: 28 days). The study lists 2 primary outcomes in all. 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 13 May 2008.