Respiratory Distress Syndrome, AdultNCT01468142
Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure
An observational study of Respiratory Distress Syndrome, Adult and Respiratory Distress Syndrome, Child, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
The purpose of this study is the observation of the course of the mechanics of the respiratory system the endexpiratory lung volume and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult, Respiratory Distress Syndrome, Child
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Dec 2016
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: General hospitals, district hospitals, specialized hospitals,
Who may be able to join
- patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.
Who cannot join
- malignant disease with a poor prognosis
- massive intracranial bleeding
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is the observation of the course of
- the mechanics of the respiratory system
- the endexpiratory lung volume
- and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.
- Medical subject headings
- Respiratory Distress Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Course of inflammatory parameters and lung function
Measured: end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress Syndrome, AdultStudies of the same condition, open and under way.
- More trials run by Karolinska 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard Holzgraefe, Karolinska University Hospital
- Investigators
- Bernhard Holzgraefe, MD, Principal investigator, Karolinska University HospitalAnders Larsson, PhD, Study chair, Uppsala University, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468142
- Sponsor's protocol ID
- 2011/1282-31/1
- Status last verified
- Dec 2016
- First submitted
- 7 Nov 2011
- Last updated
- 20 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Pathophysiology and Inflammatory Response in Patients Treated With Ecmo for Severe Respiratory Failure
- ClinicalTrials.gov ID
- NCT01468142
- Acronym / sponsor ID
- 2011/1282-31/1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 9 Nov 2011 (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 the observation of the course of
- the mechanics of the respiratory system
- the endexpiratory lung volume
- and the inflammatory response in patients undergoing treatment with extracorporeal life support (ECLS) due to severe refractory respiratory failure at our department.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- General hospitals, district hospitals, specialized hospitals,
Key inclusion criteria (1 listed)
- patients accepted for extracorporeal life support at our department due to the most severe forms of ARDS/respiratory failure not responding to conventional therapy.
Key exclusion criteria (2 listed)
- malignant disease with a poor prognosis
- massive intracranial bleeding
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
Course of inflammatory parameters and lung function
Time frame: end of treatment
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 20 Dec 2016.
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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.
Bernhard Holzgraefe, MD principal investigator
Karolinska University Hospital
Anders Larsson, PhD study chair
Uppsala University, Uppsala, Sweden
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 Respiratory Distress Syndrome, Adult and Respiratory Distress Syndrome, Child, run by Karolinska University Hospital at 1 site in Sweden.
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 1 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 20 Dec 2016. 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 Sweden. 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?
Course of inflammatory parameters and lung function (time frame: end of treatment). 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 20 Dec 2016.