Acute Respiratory Distress Syndrome (ARDS)NCT01906229
Lung and Systemic Inflammation in the Critically Ill Patient
An observational study of Acute Respiratory Distress Syndrome (ARDS) and Systemic Inflammatory Response Syndrome (SIRS), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS), Systemic Inflammatory Response Syndrome (SIRS), Sepsis
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2013to Dec 2018
- 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: Intensive care unit
Who may be able to join
- General:
- Age >18 years
- Mechanically ventilated
- < 48 hours after admission to the Intensive Care Unit
- Specific:
- -ARDS: acute (< 1 week) respiratory failure, characterized by hypoxemia (PaO2/FiO2 < 300 mmHg/40kPa), and bilateral infiltrates on x-ray or CT of thorax, that can not be explained by heart failure og overhydration.
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- OR
- SIRS (two of the following): Temperature > 38°C or < 36°C, heart rate > 90/min, respiratory frequency > 20 or PaCO2 < 4.2 kPa, leukocytosis (> 12x10^9/L) or leukopenia (< 4x10^9/L)
- OR
- ARDS + SIRS
Who cannot join
- One lung ventilation; Tube size < 8.0 mm; INR > 1.5 or thrombocytes < 40x10^9/L; Intracranial hypertension; Malignant arrythmias
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients
Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. It has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However, the time course and the possible pathways for this transmission of disease have yet to be established.
Investigators hypothesize that:
- Primary systemic inflammation is followed by a secondary pulmonary inflammatory response
- Primary pulmonary inflammation is followed by a secondary systemic inflammatory response
- Both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins')
- The inflammatory response is most pronounced in the primary afflicted compartment.
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Systemic Inflammatory Response Syndrome (SIRS), Sepsis
- Medical subject headings
- Respiratory Distress Syndrome, Systemic Inflammatory Response Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute respiratory distress syndrome (ARDS) | Not described | |
| Systemic inflammatory response syndrome (SIRS) | Not described | |
| ARDS+SIRS | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor necrosis factor alpha (TNF-a) bioactivity
Measured: Day one
Tumor necrosis factor alpha (TNF-a) bioactivity
Measured: Day three
Tumor necrosis factor alpha (TNF-a) bioactivity
Measured: Day seven
Tumor necrosis factor alpha (TNF-a) bioactivity
Measured: Day fourteen
Secondary outcomes (3)
Interleukin (IL)-6
Measured: Day one
Mannose binding lectin (MBL)
Measured: Day one
Ficolin-1,2,3
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Slow enrollment and therefore not possible to reach the estimated enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronni R. Plovsing, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01906229
- Sponsor's protocol ID
- 959521891
- Status last verified
- Dec 2018
- First submitted
- 16 Jul 2013
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pulmonary and Systemic Inflammation in Mechanically Ventilated Intensive Care Patients
- ClinicalTrials.gov ID
- NCT01906229
- Acronym / sponsor ID
- 959521891
- Conditions
- Acute Respiratory Distress Syndrome (ARDS), Systemic Inflammatory Response Syndrome (SIRS), Sepsis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment and therefore not possible to reach the estimated enrollment
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 24 Jul 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.
Acute respiratory distress syndrome (ARDS) is a devastating form of acute lung inflammation, that may be caused by a variety of insults with pulmonary and systemic infectious disease being the most common predisposing factor. Sepsis, on the other hand, represents the systemic inflammatory response to an invading pathogen, which may inflict damage upon the host through organ dysfunction. ARDS and sepsis are heterogenous clinical conditions that have a high mortality, and both diseases involve a complex interplay of different inflammatory mediators and cell types. It has been suggested that locally released inflammatory mediators pass from the lungs into the bloodstream following ARDS, triggering systemic inflammation. Conversely, it is possible that severe systemic inflammation may lead to ARDS by an influx of inflammatory mediators from the bloodstream to the lungs. However, the time course and the possible pathways for this transmission of disease have yet to be established.
Investigators hypothesize that:
- Primary systemic inflammation is followed by a secondary pulmonary inflammatory response
- Primary pulmonary inflammation is followed by a secondary systemic inflammatory response
- Both primary and secondary inflammatory responses are characterized by the appearance of pro-inflammatory cytokines, inflammatory cells and production of collagen-like proteins (termed 'lectins')
- The inflammatory response is most pronounced in the primary afflicted compartment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute respiratory distress syndrome (ARDS) | – | – |
| Systemic inflammatory response syndrome (SIRS) | – | – |
| ARDS+SIRS | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care unit
Key inclusion criteria (10 listed)
- Age >18 years
- Mechanically ventilated
- < 48 hours after admission to the Intensive Care Unit
- -ARDS: acute (< 1 week) respiratory failure, characterized by hypoxemia (PaO2/FiO2 < 300 mmHg/40kPa), and bilateral infiltrates on x-ray or CT of thorax, that can not be explained by heart failure og overhydration.
- OR
Key exclusion criteria (1 listed)
- One lung ventilation; Tube size < 8.0 mm; INR > 1.5 or thrombocytes < 40x10^9/L; Intracranial hypertension; Malignant arrythmias
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
Tumor necrosis factor alpha (TNF-a) bioactivity
Time frame: Day one
Tumor necrosis factor alpha (TNF-a) bioactivity
Time frame: Day three
Tumor necrosis factor alpha (TNF-a) bioactivity
Time frame: Day seven
Tumor necrosis factor alpha (TNF-a) bioactivity
Time frame: Day fourteen
3 secondary outcomes
Interleukin (IL)-6
Time frame: Day one
Mannose binding lectin (MBL)
Time frame: Day one
Ficolin-1,2,3
Time frame: Day one
Results and safety
The study was stopped early (reason given: Slow enrollment and therefore not possible to reach the estimated enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (ARDS) and Systemic Inflammatory Response Syndrome (SIRS), run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 10 inclusion and 1 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: stopped early, as of the sponsor's last update on 11 Dec 2018. 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 Denmark. 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 was stopped early (reason given: Slow enrollment and therefore not possible to reach the estimated enrollment). Results are not available in the source record.
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?
Tumor necrosis factor alpha (TNF-a) bioactivity (time frame: Day one). The study lists 4 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 11 Dec 2018.