PREVENTION OF VASOPLEGIA WITH THE USE OF CYTOSORB

The incidence and prevalence of chronic heart failure are 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 on 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. We
hypothesize 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. Minimalizing this SIRS reaction could be a strategy to prevent
vasoplegia.

To test the efficacy and cost-effectiveness of using CytoSorb in preventing
vasoplegia in patients with heart failure undergoing cardiac surgery on CPB.

The proposed study is an investigator-initiated single-center randomized
controlled clinical trial in patients with HF who will undergo cardiac surgery
on CPB. In total 36 patients will be enrolled. Patients will be randomized to
receive either CytoSorb treatment or standard of care without CytoSorb
treatment in a 1:1 ratio. The study intervention protocol starts on the day of
the surgery and ends 4 days postoperatively. CytoSorb treatment will be
conducted intraoperatively in the operating room. Patients' clinical data is
collected up to day 30 after heart surgery.

The investigational treatment that the patients randomized for CytoSorb
treatment will receive includes the use of the CytoSorb device in the CPB
circuit .

The treatment protocol follows the standard of care procedure except for the
CytoSorb application in the CPB circuit in the intervention group and
phenylephrine challenges, 5x2 blood samples (10 ml each, 100ml total) and
sublingual microcirculation monitoring in both study groups. The CytoSorb
device has been proven to be safe, feasible and well-tolerated during cardiac
surgeries and no major risks or side-effects have been reported. In rare cases,
a hypersensitivity reaction may occur during CPB, however no case has been
reported until now. In addition, CytoSorb is capable of removing drugs (i.e.
antibiotics, pressor agents, etc.). Therefore, the physician is advised to
measure concomitant drug concentrations when CytoSorb treatment is used if a
test is available and adjust the drug dosage accordingly. None of the drugs
used in the anaesthetics protocol is known to be adsorbed by CytoSorb.
Patients included in the intervention group may benefit from the intervention,
since we are expecting a better outcome with regards to the occurrence of
vasoplegia. Patients in the control group will not experience a direct benefit
from participating in the study. However, generation of comparative data on the
use of CytoSorb might help discover preventive options for vasoplegia, leading
to safer surgical interventions and improved outcome. The measurements
necessary to assess the defined study parameters are not expected to negatively
influence the result of treatment.