Long Term Adverse EffectsNCT03031275
Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
A study testing High-resolution computed tomography, Magnetic resonance imaging and Cognitive testing in people with Long Term Adverse Effects and Pneumonia, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska. Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Long Term Adverse Effects, Pneumonia, Acute Respiratory Distress Syndrome
- What is being tested?
- High-resolution computed tomography, Magnetic resonance imaging and Cognitive testing
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2014to Dec 2016
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009
Who cannot join
- Diseased patients
- Patients living abroad (including non-Swedish citizens)
- Patients treated for non-respiratory conditions
- Patients with a known pre-ECMO mental handicap
Trial locations and contacts
1 site in 1 country.
About this study
Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska.
Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier.
Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.
Read the detailed description
All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.
Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.
Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.
At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate < 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.
- Conditions
- Long Term Adverse Effects, Pneumonia, Acute Respiratory Distress Syndrome, Sepsis, Critical Illness, Cognitive Impairment
- Being tested
- High-resolution computed tomography, Magnetic resonance imaging, Cognitive testing
- Keywords
- extracorporeal circulation, critical care outcomes
- Medical subject headings
- Long Term Adverse Effects, Pneumonia, Respiratory Distress Syndrome, Sepsis, Critical Illness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution computed tomographyRadiation
HRCT of the thorax
Magnetic resonance imagingRadiation
MRI of the brain
Cognitive testingBehavioural
Neuropsychological testing
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.
Measured: 5-17 years after treatment
Number of participants with abnormal brain imaging assessed by magnetic resonance imaging
Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.
Measured: 5-17 years after treatment
Number of Participants With Abnormal Pulmonary function
Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
Measured: 5-17 years after treatment
Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.
Measured: 5-17 years after treatment
Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire
Measured: 5-17 years after treatment
Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36
Measured: 5-17 years after treatment
Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire
Measured: 5-17 years after treatment
Number of participants with signs of a reduced exercise tolerance
6-minute walking test
Measured: 5-17 years after treatment
Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
Measured: 5-17 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2017 (estimated)
- Study startJan 2014
- Primary completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Long Term Adverse EffectsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 31 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03031275
- Sponsor's protocol ID
- 2013/2258-31/1
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 25 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow Up of Adult Patients Treated With Extracorporeal Membrane Oxygenation for Respiratory Failure
- ClinicalTrials.gov ID
- NCT03031275
- Acronym / sponsor ID
- 2013/2258-31/1
- Conditions
- Long Term Adverse Effects, Pneumonia, Acute Respiratory Distress Syndrome, Sepsis, Critical Illness, Cognitive Impairment
- Keywords
- extracorporeal circulation, critical care outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2016 (actual)
- First posted
- 25 Jan 2017 (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.
Follow-up after treatment with Extracorporeal Membrane Oxygenation (ECMO) at the ECMO Center Karolinska.
Patients: adult survivors treated with ECMO for severe refractory respiratory failure at least 5 years earlier.
Investigations: brain and pulmonary radiographic morphology, cognitive testing, pulmonary function testing, exercise tolerance, quality of life and mood disorder screening.
Detailed description
All adult patients treated at the ECMO Center Karolinska between 1995 and July 2009 were screened for eligibility in January 2014. Patients living abroad (including non-Swedish citizens), patients treated for non-respiratory conditions, diseased patients and patients with a known pre-ECMO mental handicap were excluded.
Eligible patients were contacted, and patients who agreed to participate gave their written informed consent. All studied patients underwent the same study protocol during a day at the hospital, including a clinical interview, MRI scan of the brain, HRCT scan of the thorax, pulmonary function testing, neuropsychological examination, walking test, self assessment questionnaires for quality of life, anxiety, depression and post-traumatic stress.
Patient charts were reviewed for relevant clinical information, including age, gender, ECMO mode (venovenous or venoarterial), time in hospital, on ECMO, non-ECMO ICU and on mechanical ventilation; preexisting diseases, blood gas values and ventilator settings before initiation of ECMO treatment. Hand written clinical data from the patients´ charts from every hour with ECMO treatment was reviewed for ventilator settings, lung volumes, mean arterial pressure, hemoglobin, lactate and oxygenation parameters during an observation period, which was defined as the first 10 days on ECMO (or the entire treatment period if shorter than 10 days). This information was added to a digital database for the purpose of this study.
At the time of ECMO treatment, arterial hemoglobin oxygen saturation was measured by peripheral pulse oximetry from the right ear, finger or nose. Venous preoxygenator lactate and venous saturation values were used as indicators of sufficient (lactate < 2 mmol l-1 , SvO2 ≥ 70%) or insufficient tissue perfusion.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients treated with ECMO at the ECMO Center Karolinska 1995 - July 2009
Key exclusion criteria (4 listed)
- Diseased patients
- Patients living abroad (including non-Swedish citizens)
- Patients treated for non-respiratory conditions
- Patients with a known pre-ECMO mental handicap
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 |
|---|---|---|
| High-resolution computed tomographyHRCT of the thorax | Radiation | – |
| Magnetic resonance imagingMRI of the brain | Radiation | – |
| Cognitive testingNeuropsychological testing | Behavioural | – |
Primary outcome
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests
Time frame: 5-17 years after treatment
Wechsler Adult Intelligence Scale, 4th ed, Rey Auditory Verbal Learning Test (learning trials 1 to 5 and delayed recall), immediate recall from the Rey Complex Figure and Logical Memory I and II from Wechsler Memory Scale, 3rd ed.
Number of participants with abnormal brain imaging assessed by magnetic resonance imaging
Time frame: 5-17 years after treatment
Sagittal and axial T1- and T2-weighted images, and coronal T2-weighted and T2-weighted fluid attenuated inversion recovery (FLAIR) images. Slice thickness 4 mm. Presence of hypoxic or anoxic damage, infarctions, hemorrhages, and contusion damage were described.
Number of Participants With Abnormal Pulmonary function
Time frame: 5-17 years after treatment
Static and dynamic spirometry. Measured results as % of the expected normal values were presented.
Number of Participants With Abnormal Lungs radiographic findings assessed by high-resolution CT scan
Time frame: 5-17 years after treatment
Non-contrast spiral scan. A series for grading of pulmonary changes was reconstructed, using a high spatial resolution reconstruction algorithm with 1 mm-width, overlapping slices. Four patterns were mapped: reticular, ground-glass opacification, consolidation and decreased attenuation.
Number of participants with signs of post-traumatic stress assessed by the Trauma Screening Questionnaire
Time frame: 5-17 years after treatment
Number of participants with signs of a reduced health related quality-of-life, assessed by the Short Form-36
Time frame: 5-17 years after treatment
Number of participants with signs of a reduced Health related quality-of-life, assessed by the S:t George´s Respiratory Questionnaire
Time frame: 5-17 years after treatment
Number of participants with signs of a reduced exercise tolerance
Time frame: 5-17 years after treatment
6-minute walking test
Number of participants with signs of anxiety and depression assessed by the Hospital and Anxiety Depression Scale
Time frame: 5-17 years after 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 25 Jan 2017.
Related trials for Long Term Adverse Effects
RecruitingObservational study
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
Pregnancy Related
RecruitingPhase 4
DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease
Ischemic Heart Disease, Ischemic Heart Disease Chronic
RecruitingObservational study
Long-term Follow-up of Subjects Treated With CAR T Cells
Long Term Adverse Effects, CAR-T
RecruitingObservational study
Functional Limitations, Body Structure and Function Impairments, and Quality of Life in Adults After Surgical Treatment of Adolescent Idiopathic Scoliosis
Adolescence Idiopathic Scoliosis
Active, not recruitingObservational study
Long-Term Real-World Evidence Study to Evaluate Effectiveness, Persistence, Adherence, Safety and Tolerability of Long-acting Cabotegravir Plus Rilpivirine.
Human Immunodeficiency Virus Infection (HIV), HIV-1 Infection in Adults
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?
A study testing High-resolution computed tomography, Magnetic resonance imaging and Cognitive testing in people with Long Term Adverse Effects and Pneumonia, 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 4 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 25 Jan 2017. 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?
Number of participants with abnormal cognitive functioning assessed by the Wechsler Adult Intelligence Scale and memory tests (time frame: 5-17 years after treatment). The study lists 9 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 25 Jan 2017.