An interventional study of CytoSorb device in Heart Failure and Vasoplegia, sponsored by Leiden University Medical Center. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-13.
Sponsored by Leiden University Medical Center · Not applicable, Interventional, and Prevention
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 36 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Leiden University Medical Center is the lead sponsor of 334 studies on the registry; 110 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Heart failure patients that will receive intraoperative treatment with CytoSorb.
Device: CytoSorb device
Heart failure patients that will not receive intraoperative treatment with CytoSorb.
The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.
Delta systemic vascular resistance index (SVRi) after CPB.
The change in SVRi after the administration of phenylephrine after cessation of CPB.
Time frame: 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.
Time frame: 72 hours
Delta SVRi in ICU.
The change in SVR after the administration of phenylephrine during the postoperative day one in the Intensive Care Unit (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].
Heterogeneity index \[HI\] will be calculated as the difference between the highest MFI minus the lowest MFI and divided by the mean MFI.
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
Costs.
Market prices will be used for the CytoSorb intervention, vasopressor and inotropic medication, amount of blood transfusion products and resuscitation fluids, and reference prices from the Dutch guidelines for economic evaluations in healthcare for duration of surgery, ICU stay, and non-ICU hospital stay, hospital readmissions.
Time frame: 30 days
Plan to share: Undecided
Started Oct 2021 (actual). Primary completion is estimated for Dec 2025, 50 months after the start.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 50 months is above that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
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