Cardiopulmonary SurgeryNCT04309591
Cytosorb Therapy in Cardiac Surgery
An observational study of Cardiopulmonary Surgery and Endocarditis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Surgery, Endocarditis, Peri-operative Cytokines Levels
- What is being tested?
- CytoSorb haemoadsorption (HA) device
- Type of treatment
- Medical device
- How many people
- 249 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Oct 2019to 4 Dec 2019
- 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: patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit at the University Hospital Basel
Who may be able to join
- patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit
Who cannot join
- denial of consent for data use
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik für Herzchirurgie, Universitätsspital Basel
Basel, 4031
About this study
Official title: Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis
Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.
- Being tested
- CytoSorb haemoadsorption (HA) device
- Keywords
- cytokine clearance, cardiac surgery, CytoSorb, cytokine removal
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb haemoadsorption (HA) deviceDevice
CytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery .
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital mortality
In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption
Measured: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
Secondary outcomes (2)
time in intensive care unit (days)
time in intensive care unit (days)
Measured: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
In-Hospital time (days)
In-Hospital time (days)
Measured: hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start18 Oct 2019
- Primary completion4 Dec 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiopulmonary SurgeryStudies 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
- Retrospective
- Enrolment
- 249 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Santer, Dr. med, Principal investigator, Universitätsspital Basel, Herzchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309591
- Sponsor's protocol ID
- 2019-01740; ch19Santer
- Other IDs
- 2019
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytosorb Therapy in Cardiac Surgery - a Retrospective Study of Hemoadsorption in Patients With Endocarditis
- ClinicalTrials.gov ID
- NCT04309591
- Acronym / sponsor ID
- 2019-01740; ch19Santer
- Keywords
- cytokine clearance, cardiac surgery, CytoSorb, cytokine removal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 249 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 4 Dec 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 16 Mar 2020 (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.
Cardiopulmonary surgery is associated with inflammatory responses that can lead to systemic inflammatory responses (SIRS), organ dysfunction (MOD) and death especially in patients with endocarditis. Cytokine removal might therefore improve outcomes of patients undergoing cardiac surgery. CytoSorb is a device designed to remove cytokine (IL-6, IL-10, TNFalpha) from the blood to reduce immune reactions. This trial investigates the use of CytoSorb during cardiac surgery in patients with endocarditis at the University Hospital Basel.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit at the University Hospital Basel
Key inclusion criteria (1 listed)
- patients with endocarditis undergoing cardiac surgery with cardio-pulmonary bypass circuit
Key exclusion criteria (1 listed)
- denial of consent for data use
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 |
|---|---|---|
| CytoSorb haemoadsorption (HA) deviceCytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery . | Device | – |
Primary outcome
In-Hospital mortality
Time frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
In-Hospital mortality (number of deaths) of patients with endocarditis undergoing cardiac surgery and intra-operative CytoSorb haemoadsorption
2 secondary outcomes
time in intensive care unit (days)
Time frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
In-Hospital time (days)
Time frame: hospital stay for cardiac surgery from admission until discharge (approximately 15 days)
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 16 Mar 2020.
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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.
David Santer, Dr. med principal investigator
Universitätsspital Basel, Herzchirurgie
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 Cardiopulmonary Surgery and Endocarditis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 16 Mar 2020. 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 Switzerland. 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?
In-Hospital mortality (time frame: during hospital stay for cardiac surgery from admission until discharge (approximately 15 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 16 Mar 2020.