Heart FailureCYCLONE-LVADNCT04596813
Role of Cytosorb in Left Ventricular Assist Device Implantation
A study testing CytoSorb 300 mL device in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- CytoSorb 300 mL device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2020to 30 Jun 2025
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation
Who cannot join
- Poor spoken and/or written language comprehension
- Declined or missing informed consent
- LVAD implant planned without use of CPB
- Total Artificial Heart implantation
- Planned CPB temperature < 32 °C
- AIDS with a CD4 count of < 200/μL
Show all 11Show fewer
- Severe thrombocytopenia (PLT <50000
- Application of contrast medium on the day of surgery
- Immunosuppressive therapy or long-term therapy with corticosteroids
- Contraindication to anticoagulation with heparin
- Participation in another clinical intervention trial
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Harefield Hospital
Harefield
Nandor Marczin, 4401895823737
Louise Moss, 4401895823737
About this study
Official title: CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery.
The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.
Read the detailed description
The principle objectives of this study are:
- To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
- To investigate the feasibility, and safety of Cytosorb® treatment during CF-LVAD implantation.
- To pilot the effect of Cytosorb® treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (AKI).
- To establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to CF-LVAD implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.
- Conditions
- Heart Failure
- Being tested
- CytoSorb 300 mL device
- Keywords
- cardiac surgery, inflammation, cytokines, bypass, artificial heart known as LVAD
- Medical subject headings
- Heart Failure, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb 300 mL deviceDevice
Intra-and postoperative CytoSorb hemoadsorption
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Not described |
| standard of care and treatment with the Cytosorb® device | Active comparator | Not described Receives: Device: CytoSorb 300 mL device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in plasma IL-6 concentration
Measured: from baseline to the time of arrival to intensive care unit (approximately 4 hours).
Secondary outcomes (11)
Changes in IL-6 concentrations at various time points after surgery until ICU discharge
Measured: from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days
Incidence of serious device related adverse events from the time of enrolment through ICU discharge
Measured: from the time of enrolment through ICU discharge (approximately 7 days)
Feasibility based on number of patients eligible and receiving study intervention
Ratio of eligible patients and those receiving study intervention
Measured: From Baseline through ICU discharge (approximately 7 days)
Incidence and progression of vasoplegia
Defined as haemodynamic instability fulfilling the following criteria for at least three consecutive hours during the first 48h after ICU arrival: MAP ≤50 mmHg or SVR ≤800 dynes·s·cm- 5; CI ≥ 2.5 l·min- 1·m- 2; use of norepinephrine ≥200 ng·kg- 1·min- 1 or equivalent doses of vasopressors (epinephrine ≥200 ng·kg- 1·min- 1; dopamine ≥30 μg·kg- 1·min- 1; phenylephrine ≥2 μg·kg- 1·min- 1, or vasopressin ≥0.08 U·min- 1)
Measured: from baseline to 24 hours after surgery
Prevalence of right ventricle dysfunction
Transesophageal echocardiography indices of right ventricle dysfunction based on TAPSE, estimates of the RV-PA coupling, 3D volumetry and ventricle free wall strain
Measured: From baseline to 72 hours after surgery
Incidence and progression of Acute Kidney Injury (KDIGO criteria)
Measured: From Baseline through ICU discharge (approximately 7 days)
Prevalence of liver dysfunction
- Defined as changes in indocyanine green plasma disappearance rate masured by the LiMON® monitor
Measured: from baseline to 72 hours after surgery
Sequential Organ Failure Assessment Score (SOFA)
Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
Measured: From Baseline through ICU discharge (approximately 7 days)
Time of mechanical ventilation
Duration of invasive mechanical ventilation
Measured: From Baseline through ICU discharge (approximately 7 days)
Length of ICU stay
Measured: From Baseline through ICU discharge (approximately 7 days)
28 day mortality
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Sep 2020
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, CytoSorbents, Inc
- Responsible party
- Sponsor
- Investigators
- Nandor Marczin, MD PhD, Study chair, Imperial College LondonEric EC de Waal, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04596813
- Sponsor's protocol ID
- 18IC4535
- Acronym
- CYCLONE-LVAD
- Status last verified
- Apr 2024
- First submitted
- 23 Sep 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CYtosorb Modulation of surgiCal infLammatiON During LVAD insErtion
- ClinicalTrials.gov ID
- NCT04596813
- Acronym / sponsor ID
- CYCLONE-LVAD / 18IC4535
- Conditions
- Heart Failure
- Keywords
- cardiac surgery, inflammation, cytokines, bypass, artificial heart known as LVAD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- UMC Utrecht, CytoSorbents, Inc
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 22 Oct 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.
Mechanical circulatory support, specifically implantable continuous flow left ventricular assist device (CF-LVAD) therapy has been established as a viable treatment for rapidly deteriorating patients suffering from end stage heart failure either as bridge or alternative to heart transplantation. However, a large proportion of these patients experience severe complications in the early postoperative period including right ventricular failure or multi organ failure leading to increased mortality. The leading theory explaining these complications involves exaggerated systemic inflammatory response prior to, during and early after CF-LVAD insertion. Among the cytokines IL-6 appears to play a major role. There is increasing demonstration of the efficacy of a cytokine haemoadsorption (HA) technology in attenuating cytokine response and particularly IL-6 in various inflammatory states and emerging data on the safety of the Cytosorb® device in routine and complex cardiac surgery.
The study team hypothesizes that Cytosorb® treatment is feasible and safe in heart failure patients undergoing LVAD insertion and that it is effective in attenuating IL-6 secretion with benefit in the wider inflammatory and metabolic response to this high-risk surgery.
Detailed description
The principle objectives of this study are:
- To investigate the efficacy of Cytosorb® treatment in attenuating perioperative changes in IL-6 during CF-LVAD implantation
- To investigate the feasibility, and safety of Cytosorb® treatment during CF-LVAD implantation.
- To pilot the effect of Cytosorb® treatment on vasoplegia and organ dysfunction with specific focus on right ventricle failure, liver failure and acute kidney injury (AKI).
- To establish a collaborative biobank of patient's biological samples to allow extensive characterisation of patient phenotype prior to CF-LVAD implantation and their individual inflammatory and metabolic responses to surgery and perioperative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | – |
| standard of care and treatment with the Cytosorb® device | Active comparator | Device: CytoSorb 300 mL device |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥18 years), but ≤70 years; Scheduled for elective LVAD implantation with the use of cardiopulmonary bypass; Written informed consent for participation
Key exclusion criteria (11 listed)
- Poor spoken and/or written language comprehension
- Declined or missing informed consent
- LVAD implant planned without use of CPB
- Total Artificial Heart implantation
- Planned CPB temperature < 32 °C
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 300 mL deviceIntra-and postoperative CytoSorb hemoadsorption | Device | standard of care and treatment with the Cytosorb® device |
Primary outcome
Increase in plasma IL-6 concentration
Time frame: from baseline to the time of arrival to intensive care unit (approximately 4 hours).
11 secondary outcomes
Changes in IL-6 concentrations at various time points after surgery until ICU discharge
Time frame: from baseline, 6, 12, 24, 48 and 72 hours after surgery and at ICU discharge, approximately 7 days
Incidence of serious device related adverse events from the time of enrolment through ICU discharge
Time frame: from the time of enrolment through ICU discharge (approximately 7 days)
Feasibility based on number of patients eligible and receiving study intervention
Time frame: From Baseline through ICU discharge (approximately 7 days)
Incidence and progression of vasoplegia
Time frame: from baseline to 24 hours after surgery
Prevalence of right ventricle dysfunction
Time frame: From baseline to 72 hours after surgery
Incidence and progression of Acute Kidney Injury (KDIGO criteria)
Time frame: From Baseline through ICU discharge (approximately 7 days)
Prevalence of liver dysfunction
Time frame: from baseline to 72 hours after surgery
Sequential Organ Failure Assessment Score (SOFA)
Time frame: From Baseline through ICU discharge (approximately 7 days)
Time of mechanical ventilation
Time frame: From Baseline through ICU discharge (approximately 7 days)
Length of ICU stay
Time frame: From Baseline through ICU discharge (approximately 7 days)
28 day mortality
Time frame: 28 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- 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.
Nandor Marczin, MD PhD study chair
Imperial College London
Eric EC de Waal principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CytoSorb 300 mL device in people with Heart Failure, run by Imperial College London at 1 site in United Kingdom.
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 11 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: status not confirmed, as of the sponsor's last update on 18 Apr 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nandor Marczin (+44 1895 823 737, n.marczin@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase in plasma IL-6 concentration (time frame: from baseline to the time of arrival to intensive care unit (approximately 4 hours).). 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 18 Apr 2024.