Myocardial IschemiaPhase 1/2CCCCNCT02775123
Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass
A Phase 1/2 study testing Cytosorb in people with Myocardial Ischemia and Heart Valve Diseases, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Ischemia, Heart Valve Diseases
- What is being tested?
- Cytosorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2016to Jan 2018
- Phase
- Phase 1/2
- 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
- Patients planned for elective cardiac surgery requiring CPB and (≥1 among):
- Age >75 years' old AND / OR
- Double valvular replacement AND / OR
- Complex surgery with expected CPB time >120 min AND / OR
- Redo cardiac surgery AND / OR
- Pre-op chronic renal failure (GFR<30 ml/min) AND / OR Chronic heart failure (LVEF <40%)
Who cannot join
- End stage renal disease (dialysis dependence)
- Emergency procedure
- Active infectious endocarditis
- Off-pump procedure planned
- Non steroidal anti-inflammatory treatment in the previous 7 days
- Corticosteroids administration in the previous 7 days
- No informed consent
- Enrolment in another conflicting study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study
Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery.
Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)].
Read more
Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded.
Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm).
For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.
Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality.
Recruitment period should span from May 2016 to April 2017.
- Conditions
- Myocardial Ischemia, Heart Valve Diseases
- Being tested
- Cytosorb
- Medical subject headings
- Myocardial Ischemia, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytosorbDevice
A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Conventional cardio-pulmonary bypass |
| Cytosorb | Experimental | Cytosorb added to cardio-pulmonary bypass Receives: Device: Cytosorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cytokine levels
Measured: From Baseline (Preoeratively) to 6hrs post CPB
Secondary outcomes (8)
Change in Cytokine levels
Measured: From Baseline (Preoeratively) to 24 hrs post CPB
Change in Cytokine levels
Measured: From Baseline (Preoeratively) to end of CPB
Change in Coagulation factors serum levels
Measured: From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB
Duration of the need for vasopressors
Measured: 28 days
Duration of mechanical ventilation
Measured: 28 days
ICU length of stay
Measured: 90 days
Hospital Length of stay
Measured: 90 days
In-hospital mortality
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2018
- Study completionJan 2018
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 Myocardial IschemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Schneider, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02775123
- Sponsor's protocol ID
- 2015-00010
- Other IDs
- 2015
- Acronym
- CCCC
- Status last verified
- Jan 2018
- First submitted
- 21 Apr 2016
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Poli EC, Alberio L, Bauer-Doerries A, Marcucci C, Roumy A, Kirsch M, De Stefano E, Liaudet L, Schneider AG. Cytokine clearance with CytoSorb(R) during cardiac surgery: a pilot randomized controlled trial. Crit Care. 2019 Apr 3;23(1):108. doi: 10.1186/s13054-019-2399-4.
PubMed 30944029
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Clearance With Cytoabsorbant Device During Cardiac Bypass: a Pilot Study
- ClinicalTrials.gov ID
- NCT02775123
- Acronym / sponsor ID
- CCCC / 2015-00010
- Conditions
- Myocardial Ischemia, Heart Valve Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 17 May 2016 (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.
Investigators are planning a single center pilot randomized controlled trial to assess the potential of a Cytoadsorbant filter (Cytosorb®, Germany) to remove cytokines from the blood during cardiac surgery.
Investigators will screen all patients undergoing cardiac surgery and approach those deemed at risk of post surgical complications [≥ 1 among: age >75 years old, double valvular replacement, complex surgery with expected CPB time >100 min, redo cardiac surgery, pre-op chronic renal failure (plasma creatinine level >120 mcmol/l) or chronic heart failure (LVEF <35%)].
Patients with end-stage renal disease (dialysis dependence), undergoing an emergency procedure or an off-pump procedure, those who decline informed consent as well as those enrolled in another conflicting study will be excluded.
Eligible patients will be approached, consented and enrolled in the trial. Patients will then be randomized to either receive conventional CPB (control arm) or CPB plus Cytosorb (intervention arm). The target population is 30 patients (15 per arm).
For this pilot study, investigators main outcome will be differences between the two arms in measurement of serum levels for IL-2, IL-6, IL-10 and TNF alpha at baseline (pre-operatively), on ICU admission, as well as 6 and 24 hrs post CPB.
Secondary outcomes will be changes in coagulation factors serum levels, the need for vasopressors, inotropes, mechanical ventilation and renal replacement therapy, ICU and hospital length of stay as well as in-hospital mortality.
Recruitment period should span from May 2016 to April 2017.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Conventional cardio-pulmonary bypass |
| Cytosorb | Experimental | Device: CytosorbCytosorb added to cardio-pulmonary bypass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients planned for elective cardiac surgery requiring CPB and (≥1 among):
Key exclusion criteria (8 listed)
- End stage renal disease (dialysis dependence)
- Emergency procedure
- Active infectious endocarditis
- Off-pump procedure planned
- Non steroidal anti-inflammatory treatment in the previous 7 days
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 |
|---|---|---|
| CytosorbA cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB). | Device | Cytosorb |
Primary outcome
Change in Cytokine levels
Time frame: From Baseline (Preoeratively) to 6hrs post CPB
8 secondary outcomes
Change in Cytokine levels
Time frame: From Baseline (Preoeratively) to 24 hrs post CPB
Change in Cytokine levels
Time frame: From Baseline (Preoeratively) to end of CPB
Change in Coagulation factors serum levels
Time frame: From baseline (pre-operatively) to end of CPB as well as 6 hrs and 24 hrs post CPB
Duration of the need for vasopressors
Time frame: 28 days
Duration of mechanical ventilation
Time frame: 28 days
ICU length of stay
Time frame: 90 days
Hospital Length of stay
Time frame: 90 days
In-hospital mortality
Time frame: 90 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 25 Jan 2018.
- Derived from this study: PubMed 30944029Poli EC, Alberio L, Bauer-Doerries A, Marcucci C, Roumy A, Kirsch M, De Stefano E, Liaudet L, Schneider AG. Cytokine clearance with CytoSorb(R) during cardiac surgery: a pilot randomized controlled trial. Crit Care. 2019 Apr 3;23(1):108. doi: 10.1186/s13054-019-2399-4.
- Individual participant dataSharing planned: No
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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?
A Phase 1/2 study testing Cytosorb in people with Myocardial Ischemia and Heart Valve Diseases, run by Centre Hospitalier Universitaire Vaudois 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 6 inclusion and 8 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 2018. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Cytokine levels (time frame: From Baseline (Preoeratively) to 6hrs post CPB). 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 NCT02775123, 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 25 Jan 2018.