Medical Condition Requiring Extracorporeal Organ SupportNCT05811780
The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry
An observational study of Medical Condition Requiring Extracorporeal Organ Support, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medical Condition Requiring Extracorporeal Organ Support
- How many people
- 1,500 participants
- Where
- 1 siteGermany
- Study dates
- 29 Apr 2014to 31 Dec 2035
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients receiving extracorporeal organ support and being treated in the Department of Interdisciplinary Medical Intensive Care of the Freiburg University Medical Center
Who may be able to join
- Treatment with any kind of extracorporeal organ support
Who cannot join
- none
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University of Freiburg Medical Center
Freiburg im Breisgau, 79106
Tobias Wengenmayer, Prof. Dr., +49761270 ext. 35910, tobias.wengenmayer@uniklinik-freiburg.de
About this study
A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.
- Keywords
- Acute Respiratory Distress Syndrome, acute respiratory failure, severe respiratory failure, cardiogenic shock, cardiac arrest, extracorporeal cardiopulmonary resuscitation
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Insufficiency, Shock, Cardiogenic, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital survival
Survival of index hospitalization (yes/no)
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start29 Apr 2014
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Condition Requiring Extracorporeal Organ SupportStudies of the same condition, open and under way.
- 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
- 1,500 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PD Dr. Alexander Supady, University Hospital Freiburg
- Investigators
- Tobias Wengenmayer, Prof. Dr., Study director, University of FreiburgDawid L Staudacher, PD Dr., Principal investigator, University of FreiburgPaul M Biever, Dr., Principal investigator, University of FreiburgJonathan Rilinger, PD Dr., Principal investigator, University of FreiburgAlexander Supady, PD Dr., Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811780
- Sponsor's protocol ID
- 151/14
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry
- ClinicalTrials.gov ID
- NCT05811780
- Acronym / sponsor ID
- 151/14
- Keywords
- Acute Respiratory Distress Syndrome, acute respiratory failure, severe respiratory failure, cardiogenic shock, cardiac arrest, extracorporeal cardiopulmonary resuscitation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 29 Apr 2014 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 Apr 2023 (actual)
- 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.
A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients receiving extracorporeal organ support and being treated in the Department of Interdisciplinary Medical Intensive Care of the Freiburg University Medical Center
Key inclusion criteria (1 listed)
- Treatment with any kind of extracorporeal organ support
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.
Primary outcome
Hospital survival
Time frame: 30 days
Survival of index hospitalization (yes/no)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: No
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.
Tobias Wengenmayer, Prof. Dr. study director
University of Freiburg
Dawid L Staudacher, PD Dr. principal investigator
University of Freiburg
Paul M Biever, Dr. principal investigator
University of Freiburg
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 Medical Condition Requiring Extracorporeal Organ Support, run by University Hospital Freiburg at 1 site in Germany.
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: looking for participants now, as of the sponsor's last update on 13 Apr 2023. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tobias Wengenmayer, Prof. Dr. (+49761270 ext. 35910, tobias.wengenmayer@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital survival (time frame: 30 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 13 Apr 2023.