Long Term OutcomeNCT01763060
Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure
An observational study of Long Term Outcome, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Long Term Outcome
- What is being tested?
- CT scan, Cognitive function and MRI
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2012to Oct 2013
- 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 to 60 years
- All sexes
- Adult
Study population: All patients who survived ECMO treatment due to infection with Influenza A/H1N1 2009 up to 3 years after discharge from hospital
Who may be able to join
- Survivors of ECMO treatment for influenza a/h1n1 pneumonia during 2009/2010 pandemics at the ECMO Center Karolinska
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. This study investigates the long term outcome of all patients who are still alive three years after ECMO treatment for severe respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.
- Conditions
- Long Term Outcome
- Being tested
- CT scan, Cognitive function, MRI
- Keywords
- ards, ecmo, h1n1, pandemics
- Medical subject headings
- Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanRadiation
Cognitive functionBehavioural
MRIRadiation
| Study group | Role | What they receive |
|---|---|---|
| ECMO survivors | CT scan of the chest of all ECMO survivors after 2009/2010 pandemics Tests for cognitive function MRI of the brain Lung function Receives: Radiation: CT scan; Behavioral: Cognitive function; Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung function
Measured: 3 years after ecmo treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Long Term OutcomeStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University Hospital
- Responsible party
- Principal investigator, Bernhard Holzgraefe, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763060
- Sponsor's protocol ID
- Dnr 2012/986-31/3
- Other IDs
- Long term outcome
- Status last verified
- Nov 2013
- First submitted
- 4 Jan 2013
- Last updated
- 21 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Holzgraefe B, Andersson C, Kalzen H, von Bahr V, Mosskin M, Larsson EM, Palmer K, Frenckner B, Larsson A. Does permissive hypoxaemia during extracorporeal membrane oxygenation cause long-term neurological impairment?: A study in patients with H1N1-induced severe respiratory failure. Eur J Anaesthesiol. 2017 Feb;34(2):98-103. doi: 10.1097/EJA.0000000000000544.
PubMed 28030441
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow up of Patients Who Were Treated With Extracorporeal Membrane Oxygenation for Pandemic Influenza A/H1N1 Induced Severe Respiratory Failure
- ClinicalTrials.gov ID
- NCT01763060
- Acronym / sponsor ID
- Dnr 2012/986-31/3
- Conditions
- Long Term Outcome
- Keywords
- ards, ecmo, h1n1, pandemics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- Karolinska Institutet, Uppsala University Hospital
- Study start
- Oct 2012
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 8 Jan 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.
Patients treated with Extracorporeal Membrane Oxygenation (ecmo) for severe respiratory or circulatory failure show severe long term disability due to impaired lung -, cerebral-, cognitive function and impaired quality of life. This study investigates the long term outcome of all patients who are still alive three years after ECMO treatment for severe respiratory failure during the H1N1 2009 pandemic at the Karolinska University Hospital.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECMO survivors | – | Radiation: CT scan, Behavioral: Cognitive function, Radiation: MRICT scan of the chest of all ECMO survivors after 2009/2010 pandemics Tests for cognitive function MRI of the brain Lung function |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Age groups
- Adult
- Study population
- All patients who survived ECMO treatment due to infection with Influenza A/H1N1 2009 up to 3 years after discharge from hospital
Key inclusion criteria (1 listed)
- Survivors of ECMO treatment for influenza a/h1n1 pneumonia during 2009/2010 pandemics at the ECMO Center Karolinska
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CT scan | Radiation | ECMO survivors |
| Cognitive function | Behavioural | ECMO survivors |
| MRI | Radiation | ECMO survivors |
Primary outcome
Lung function
Time frame: 3 years after ecmo 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 21 Nov 2013.
- Derived from this study: PubMed 28030441Holzgraefe B, Andersson C, Kalzen H, von Bahr V, Mosskin M, Larsson EM, Palmer K, Frenckner B, Larsson A. Does permissive hypoxaemia during extracorporeal membrane oxygenation cause long-term neurological impairment?: A study in patients with H1N1-induced severe respiratory failure. Eur J Anaesthesiol. 2017 Feb;34(2):98-103. doi: 10.1097/EJA.0000000000000544.
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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 Long Term Outcome, 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 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: finished, as of the sponsor's last update on 21 Nov 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 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?
Lung function (time frame: 3 years after ecmo treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01763060, which also lists 1 linked publication.
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 21 Nov 2013.