Clinical trial NCT04812717: Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb.
Official title: Prevention of Vasoplegia With the Use of CytoSorb.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Vasoplegia
Keywords: Heat Failure
Vasoplegia
Cardiopulmonary Bypass
Systemic Inflammatory Response Syndrome
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Delta systemic vascular resistance index (SVRi) after CPB.
timeFrame: during surgery (2-10 hours)
measure: Incidence of vasoplegia.
timeFrame: 72 hours
Secondary outcomes:
measure: Delta SVRi in ICU.
timeFrame: postoperative day 1
measure: Total administered dosage of vasopressors.
timeFrame: 30 days
measure: Change in IL-6, IL-8, IL-10 levels.
timeFrame: until postoperative day 4 (96 hours)
measure: Change in microvascular flow index [MFI],heterogeneity index [HI].
timeFrame: until postoperative day 4 (96 hours)
measure: Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD].
timeFrame: until postoperative day 4 (96 hours)
measure: Change in proportion of perfused vessels [PPV].
timeFrame: until postoperative day 4 (96 hours)
measure: Change in rolling leucocytes [RL] levels.
timeFrame: until postoperative day 4 (96 hours)
measure: Change in mean cell velocity [MCV], red blood cell velocity [RBCv].
timeFrame: until postoperative day 4 (96 hours)
measure: Change in capillary hematocrit.
timeFrame: until postoperative day 4 (96 hours)
measure: Change in mean arterial pressure (MAP) after phenylephrine administration.
timeFrame: until postoperative day 1 (24 hours)
measure: Hours on mechanical ventilation.
timeFrame: 30 days
measure: Hours on mechanical circulatory support.
timeFrame: 30 days
measure: Hours on postoperative renal replacement therapy.
timeFrame: 30 days
measure: End organ damage (kidney dysfunction).
timeFrame: 30 days
measure: Change in total Sequential Organ Failure Assessment Score (SOFA).
timeFrame: 30 days
measure: Amount of used resuscitation fluids.
timeFrame: 30 days
measure: Amount of used blood transfusion products.
timeFrame: 30 days
measure: Length of ICU stay.
timeFrame: 30 days
measure: Length of hospital stay.
timeFrame: 30 days
measure: 30-Day hospital readmissions.
timeFrame: 30 days
measure: All-cause mortality.
timeFrame: 30 days
Other outcomes:
measure: Costs.
timeFrame: 30 days
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Meindert Palmen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.