ARDSARDSNCT01967602
Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support
An observational study of ARDS and Multi-organ Failure, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Multi-organ Failure
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- Oct 2011to Apr 2015
- 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 who are admitted to National Taiwan University Hospital for acute respiratory distress syndrome needing ECMO placement.
Who may be able to join
- >18 years old
- ARDS, needing ECMO support
Who cannot join
- pre-existing sepsis
- pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei
Shuenn-Wen Kuo, MD, 0972651448, shuenn@ntuh.gov.tw
About this study
The goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.
Read the detailed description
The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.
- Conditions
- ARDS, Multi-organ Failure
- Keywords
- Acute respiratory distress syndrome (ARDS), Extracorporeal membrane oxygenation (ECMO), biomarker
- Medical subject headings
- Multiple Organ Failure, Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality or multi-organ failure
Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startOct 2011
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDSStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shuenn-Wen Kuo, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967602
- Sponsor's protocol ID
- 201103056RB
- Acronym
- ARDS
- Status last verified
- Oct 2013
- First submitted
- 18 Oct 2013
- Last updated
- 23 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarker of Lung Injury in ARDS Patients Receiving ECMO Support
- ClinicalTrials.gov ID
- NCT01967602
- Acronym / sponsor ID
- ARDS / 201103056RB
- Conditions
- ARDS, Multi-organ Failure
- Keywords
- Acute respiratory distress syndrome (ARDS), Extracorporeal membrane oxygenation (ECMO), biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 23 Oct 2013 (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 goal of this project is to find a marker expression that the investigators can use to trace symptom progression and develop a more efficient therapy to enhance ARDS patient survival rate and better post-ICU life quality.
Detailed description
The investigators will first identify acute respiratory distress syndrome (ARDS) patients receiving ECMO support in ICU at National Taiwan University Hospital, and then collect blood, urine and bronchioalveolar lavage fluid (BALF) samples at different time points: before setting up ECMO, 2, 6, 12, 24, 72 hours,5 and 14 days after ECMO installment, time to wean ECMO and the day removing ECMO and leaving ICU. From the samples, the free radicals, cytokines (IL-1, IL-6, IL-8, IL-18,tumor necrosis factor-α, transforming growth factor-β), and inflammasome- related markers, immune cell responses and other biochemical markers would be measured. The novel biomarkers to predict the outcome of the patient will be identified.
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 who are admitted to National Taiwan University Hospital for acute respiratory distress syndrome needing ECMO placement.
Key inclusion criteria (2 listed)
- >18 years old
- ARDS, needing ECMO support
Key exclusion criteria (2 listed)
- pre-existing sepsis
- pre-existing chronic renal failure (dialysis dependent), liver failure other diseases precluding chance of survival.
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
Mortality or multi-organ failure
Time frame: 7 days
Patients who survived for more than 7 days after ECMO treatment were defined as survival, and non-survival patients were defined as expired or multiple organ failure incompatible with life within 7 days after ECMO installation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
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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.
Shuenn-Wen Kuo, MD 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 ARDS and Multi-organ Failure, 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: status not confirmed, as of the sponsor's last update on 23 Oct 2013. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality or multi-organ failure (time frame: 7 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 23 Oct 2013.