Heart FailureCytoSorb-HFNCT04812717
Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb.
A study testing CytoSorb device in people with Heart Failure and Vasoplegia, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Vasoplegia is a common complication after heart surgery for heart failure. With vasoplegia, the blood vessels can no longer squeeze properly, causing low blood pressure that is sometimes difficult to treat with medication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Vasoplegia
- What is being tested?
- CytoSorb device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteNetherlands
- Study dates
- 27 Oct 2021to 31 Jan 2026
- 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
- Diagnosed with HF in line with the European Society of Cardiology (ESC) guidelines34;
- Left ventricular EF ≤35%;
- Undergoing cardiac surgery on CPB with an anticipated duration of >120 minutes;
- Age ≥18 years.
Who cannot join
- Incapacitated;
- Emergency operation;
- Need for moderate or high dosages of intravenous inotropic support (>4 gamma dobutamine or dopamine) and/or vasopression;
- Severe tricuspid regurgitation;
- Daily use of nitroglycerine or isosorbide dinitrate;
- Use of alpha blockers;
- Being heparin-induced thrombocytopenia (HIT) positive and citrate regional anticoagulation is unavailable as an alternative anticoagulation method;
- Platelet count <20,000/μL.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden
Olga Papazisi, MD, +31 71 5264022, o.papazisi@lumc.nl
Meindert Palmen, MD PhD
About this study
Official title: Prevention of Vasoplegia With the Use of CytoSorb.
Vasoplegia is a common complication after heart surgery for heart failure. With vasoplegia, the blood vessels can no longer squeeze properly, causing low blood pressure that is sometimes difficult to treat with medication. One of the causes of this complication is likely to be the use of the heart-lung machine, a device that takes over the function of the heart and lungs during surgery. The blood then comes into contact with a foreign environment and this can cause a reaction of the immune system. Patients with heart failure are extra sensitive to this reaction.
CytoSorb device is a filter that can be built into the heart-lung machine and can reduce the response of the immune system. Therefore, this study aims to investigate whether the use of this filter during heart surgery in patients with heart failure results in a less frequent occurrence of vasoplegia after surgery.
Read the detailed description
The incidence and prevalence of chronic heart failure is increasing. Despite the expansion of therapeutic options, overall survival and quality-of-life remain poor. When optimal medical therapy and cardiological interventions have failed to improve a patient's condition, surgical intervention may be a valid option in order to improve cardiac function. Different surgical treatments have improved clinical outcome. Unfortunately, heart failure surgery is associated with an increased risk of vasoplegia. This syndrome is characterized by hypotension and the continuous need of vasopressors, despite a normal or high cardiac index. The incidence of vasoplegia ranges from 11-31% in patients undergoing heart failure surgery. The prognosis of vasoplegia is poor. Prolonged hypotension and the accompanying hypoperfusion lead to end-organ dysfunction and is associated with an increased morbidity and mortality. The investigators hypothesise that the balance of the vascular system of patients with heart failure is fragile and therefore could easily be disturbed by a systemic inflammatory response syndrome (SIRS) caused by the cardiopulmonary bypass (CPB) and surgical trauma, making these patients more prone to develop vasoplegia. Minimising this SIRS reaction could be a strategy to prevent vasoplegia. Therefore, the objective of this single-center, investigator-initiated study is to analyse the efficacy and cost-effectiveness of using CytoSorb in preventing vasoplegia in patients with heart failure undergoing cardiac surgery on CPB.
CytoSorb treatment will be conducted intraoperatively and the device will be applied in a parallel circuit in the CPB. The total study intervention protocol takes 5 days and starts on the day of the surgery (day 0) and ends at day 4 postoperatively. Patient clinical data will be collected until day 30.
The vascular reactivity in response to a vasoconstrictor will be assessed in all patients at 3 different time points (after induction, after CPB, on day 1 postoperatively). During the vasoconstriction test, a bolus of 2 μg/kg phenylephrine is administered intravenously, after which the effect on the systemic vascular resistance is registered. At the same time points and in addition, before induction (baseline) and on day 4 the sublingual microcirculation will be monitored and blood samples will be collected.
- Conditions
- Heart Failure, Vasoplegia
- Being tested
- CytoSorb device
- Keywords
- Heat Failure, Vasoplegia, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Heart Failure, Vasoplegia, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb deviceDevice
The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb-Yes | Active comparator | Heart failure patients that will receive intraoperative treatment with CytoSorb. Receives: Device: CytoSorb device |
| CytoSorb-No | No intervention | Heart failure patients that will not receive intraoperative treatment with CytoSorb. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delta systemic vascular resistance index (SVRi) after CPB.
The change in SVRi after the administration of phenylephrine after cessation of CPB.
Measured: during surgery (2-10 hours)
Incidence of vasoplegia.
Vasoplegic syndrome defined as the continuous need of vasopressors (norepinephrine ≥0.2 μg/kg/min for at least 12 consecutive hours, terlipressin, or methylene blue) in combination with a cardiac index (CI) ≥2.2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively.
Measured: 72 hours
Secondary outcomes (21)
Delta SVRi in ICU.
The change in SVR after the administration of phenylephrine during the postoperative day one in the Intensive Care Unit (ICU).
Measured: postoperative day 1
Total administered dosage of vasopressors.
Measured: 30 days
Change in IL-6, IL-8, IL-10 levels.
Measured: until postoperative day 4 (96 hours)
Change in microvascular flow index [MFI],heterogeneity index [HI].
Heterogeneity index [HI] will be calculated as the difference between the highest MFI minus the lowest MFI and divided by the mean MFI.
Measured: until postoperative day 4 (96 hours)
Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD].
Measured: until postoperative day 4 (96 hours)
Change in proportion of perfused vessels [PPV].
Measured: until postoperative day 4 (96 hours)
Change in rolling leucocytes [RL] levels.
Measured: until postoperative day 4 (96 hours)
Change in mean cell velocity [MCV], red blood cell velocity [RBCv].
Measured: until postoperative day 4 (96 hours)
Change in capillary hematocrit.
Measured: until postoperative day 4 (96 hours)
Change in mean arterial pressure (MAP) after phenylephrine administration.
Measured: until postoperative day 1 (24 hours)
Hours on mechanical ventilation.
Measured: 30 days
Hours on mechanical circulatory support.
Measured: 30 days
Hours on postoperative renal replacement therapy.
Measured: 30 days
End organ damage (kidney dysfunction).
Measured: 30 days
Change in total Sequential Organ Failure Assessment Score (SOFA).
Measured: 30 days
Amount of used resuscitation fluids.
Measured: 30 days
Amount of used blood transfusion products.
Measured: 30 days
Length of ICU stay.
Measured: 30 days
Length of hospital stay.
Measured: 30 days
30-Day hospital readmissions.
Measured: 30 days
All-cause mortality.
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 posted24 Mar 2021
- Study start27 Oct 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
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 Heart FailureStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meindert Palmen, Leiden University Medical Center
- Investigators
- Meindert Palmen, MD, PhD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812717
- Sponsor's protocol ID
- P20.039
- Other IDs
- NL71623.058.20
- Acronym
- CytoSorb-HF
- Status last verified
- Dec 2023
- First submitted
- 16 Mar 2021
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Papazisi O, Bruggemans EF, Berendsen RR, Hugo JDV, Lindeman JHN, Beeres SLMA, Arbous MS, van den Hout WB, Mertens BJA, Ince C, Klautz RJM, Palmen M. Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 19;12(9):e061337. doi: 10.1136/bmjopen-2022-061337.
PubMed 36123067
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Vasoplegia With the Use of CytoSorb.
- ClinicalTrials.gov ID
- NCT04812717
- Acronym / sponsor ID
- CytoSorb-HF / P20.039
- Conditions
- Heart Failure, Vasoplegia
- Keywords
- Heat Failure, Vasoplegia, Cardiopulmonary Bypass, Systemic Inflammatory Response Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 24 Mar 2021 (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.
Vasoplegia is a common complication after heart surgery for heart failure. With vasoplegia, the blood vessels can no longer squeeze properly, causing low blood pressure that is sometimes difficult to treat with medication. One of the causes of this complication is likely to be the use of the heart-lung machine, a device that takes over the function of the heart and lungs during surgery. The blood then comes into contact with a foreign environment and this can cause a reaction of the immune system. Patients with heart failure are extra sensitive to this reaction.
CytoSorb device is a filter that can be built into the heart-lung machine and can reduce the response of the immune system. Therefore, this study aims to investigate whether the use of this filter during heart surgery in patients with heart failure results in a less frequent occurrence of vasoplegia after surgery.
Detailed description
The incidence and prevalence of chronic heart failure is increasing. Despite the expansion of therapeutic options, overall survival and quality-of-life remain poor. When optimal medical therapy and cardiological interventions have failed to improve a patient's condition, surgical intervention may be a valid option in order to improve cardiac function. Different surgical treatments have improved clinical outcome. Unfortunately, heart failure surgery is associated with an increased risk of vasoplegia. This syndrome is characterized by hypotension and the continuous need of vasopressors, despite a normal or high cardiac index. The incidence of vasoplegia ranges from 11-31% in patients undergoing heart failure surgery. The prognosis of vasoplegia is poor. Prolonged hypotension and the accompanying hypoperfusion lead to end-organ dysfunction and is associated with an increased morbidity and mortality. The investigators hypothesise that the balance of the vascular system of patients with heart failure is fragile and therefore could easily be disturbed by a systemic inflammatory response syndrome (SIRS) caused by the cardiopulmonary bypass (CPB) and surgical trauma, making these patients more prone to develop vasoplegia. Minimising this SIRS reaction could be a strategy to prevent vasoplegia. Therefore, the objective of this single-center, investigator-initiated study is to analyse the efficacy and cost-effectiveness of using CytoSorb in preventing vasoplegia in patients with heart failure undergoing cardiac surgery on CPB.
CytoSorb treatment will be conducted intraoperatively and the device will be applied in a parallel circuit in the CPB. The total study intervention protocol takes 5 days and starts on the day of the surgery (day 0) and ends at day 4 postoperatively. Patient clinical data will be collected until day 30.
The vascular reactivity in response to a vasoconstrictor will be assessed in all patients at 3 different time points (after induction, after CPB, on day 1 postoperatively). During the vasoconstriction test, a bolus of 2 μg/kg phenylephrine is administered intravenously, after which the effect on the systemic vascular resistance is registered. At the same time points and in addition, before induction (baseline) and on day 4 the sublingual microcirculation will be monitored and blood samples will be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytoSorb-Yes | Active comparator | Device: CytoSorb deviceHeart failure patients that will receive intraoperative treatment with CytoSorb. |
| CytoSorb-No | No intervention | –Heart failure patients that will not receive intraoperative treatment with CytoSorb. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with HF in line with the European Society of Cardiology (ESC) guidelines34;
- Left ventricular EF ≤35%;
- Undergoing cardiac surgery on CPB with an anticipated duration of >120 minutes;
- Age ≥18 years.
Key exclusion criteria (8 listed)
- Incapacitated;
- Emergency operation;
- Need for moderate or high dosages of intravenous inotropic support (>4 gamma dobutamine or dopamine) and/or vasopression;
- Severe tricuspid regurgitation;
- Daily use of nitroglycerine or isosorbide dinitrate;
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 deviceThe CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation. | Device | CytoSorb-Yes |
Primary outcome
Delta systemic vascular resistance index (SVRi) after CPB.
Time frame: during surgery (2-10 hours)
The change in SVRi after the administration of phenylephrine after cessation of CPB.
Incidence of vasoplegia.
Time frame: 72 hours
Vasoplegic syndrome defined as the continuous need of vasopressors (norepinephrine ≥0.2 μg/kg/min for at least 12 consecutive hours, terlipressin, or methylene blue) in combination with a cardiac index (CI) ≥2.2 l/min/m2 for at least 12 consecutive hours, starting within the first 3 days postoperatively.
21 secondary outcomes
Delta SVRi in ICU.
Time frame: postoperative day 1
Total administered dosage of vasopressors.
Time frame: 30 days
Change in IL-6, IL-8, IL-10 levels.
Time frame: until postoperative day 4 (96 hours)
Change in microvascular flow index [MFI],heterogeneity index [HI].
Time frame: until postoperative day 4 (96 hours)
Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD].
Time frame: until postoperative day 4 (96 hours)
Change in proportion of perfused vessels [PPV].
Time frame: until postoperative day 4 (96 hours)
Change in rolling leucocytes [RL] levels.
Time frame: until postoperative day 4 (96 hours)
Change in mean cell velocity [MCV], red blood cell velocity [RBCv].
Time frame: until postoperative day 4 (96 hours)
Change in capillary hematocrit.
Time frame: until postoperative day 4 (96 hours)
Change in mean arterial pressure (MAP) after phenylephrine administration.
Time frame: until postoperative day 1 (24 hours)
Hours on mechanical ventilation.
Time frame: 30 days
Hours on mechanical circulatory support.
Time frame: 30 days
Hours on postoperative renal replacement therapy.
Time frame: 30 days
End organ damage (kidney dysfunction).
Time frame: 30 days
Change in total Sequential Organ Failure Assessment Score (SOFA).
Time frame: 30 days
Amount of used resuscitation fluids.
Time frame: 30 days
Amount of used blood transfusion products.
Time frame: 30 days
Length of ICU stay.
Time frame: 30 days
Length of hospital stay.
Time frame: 30 days
30-Day hospital readmissions.
Time frame: 30 days
All-cause mortality.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Derived from this study: PubMed 36123067Papazisi O, Bruggemans EF, Berendsen RR, Hugo JDV, Lindeman JHN, Beeres SLMA, Arbous MS, van den Hout WB, Mertens BJA, Ince C, Klautz RJM, Palmen M. Prevention of vasoplegia with CytoSorb in heart failure patients undergoing cardiac surgery (CytoSorb-HF trial): protocol for a randomised controlled trial. BMJ Open. 2022 Sep 19;12(9):e061337. doi: 10.1136/bmjopen-2022-061337.
- Individual participant dataSharing planned: Undecided
Related trials for Heart Failure
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruiting
RELIEVE-HFrEF TRIAL: REducing Lung congestIon Symptoms Using the v-wavE Shunt in adVancEd Heart Failure With Reduced EF
Heart Failure and Reduced Ejection Fraction, Heart Failure Chronic
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.
Meindert Palmen, MD, PhD principal investigator
Leiden University Medical Center
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 device in people with Heart Failure and Vasoplegia, run by Leiden University Medical Center at 1 site in Netherlands.
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 4 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 Netherlands. 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 Olga Papazisi, MD (+31715264022, o.papazisi@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delta systemic vascular resistance index (SVRi) after CPB. (time frame: during surgery (2-10 hours)). The study lists 2 primary outcomes in all. 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 NCT04812717, 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 13 Dec 2023.