Prevention of Low Blood Pressure After Cardiac Surgery in Heart Failure Patients With a Filter Called CytoSorb.

Heart Failure Clinical Trial

— CytoSorb-HF  

Official title:

Prevention of Vasoplegia With the Use of CytoSorb.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04812717
• Other study ID #: P20.039
• Secondary ID: NL71623.058.20
• Status: Recruiting
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: January 31, 2026

Study information

• Verified date: December 2023
• Source: Leiden University Medical Center
• Contact: Olga Papazisi, MD
• Phone: +31715264022
• Email: o.papazisi[@]lumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: January 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure
• Vasoplegia

Intervention

Device:
• CytoSorb device
The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.

Locations

Country	Name	City	State
Netherlands	Leiden University Medical Center	Leiden

Sponsors (1)

Lead Sponsor	Collaborator
Leiden University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	30 days
Primary	Delta systemic vascular resistance index (SVRi) after CPB.	The change in SVRi after the administration of phenylephrine after cessation of CPB.	during surgery (2-10 hours)
Primary	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.	72 hours
Secondary	Delta SVRi in ICU.	The change in SVR after the administration of phenylephrine during the postoperative day one in the Intensive Care Unit (ICU).	postoperative day 1
Secondary	Total administered dosage of vasopressors.		30 days
Secondary	Change in IL-6, IL-8, IL-10 levels.		until postoperative day 4 (96 hours)
Secondary	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.	until postoperative day 4 (96 hours)
Secondary	Change in capillary density, functional capillary density [FCD], total vessel density [TVD], perfused vessel density [PVD].		until postoperative day 4 (96 hours)
Secondary	Change in proportion of perfused vessels [PPV].		until postoperative day 4 (96 hours)
Secondary	Change in rolling leucocytes [RL] levels.		until postoperative day 4 (96 hours)
Secondary	Change in mean cell velocity [MCV], red blood cell velocity [RBCv].		until postoperative day 4 (96 hours)
Secondary	Change in capillary hematocrit.		until postoperative day 4 (96 hours)
Secondary	Change in mean arterial pressure (MAP) after phenylephrine administration.		until postoperative day 1 (24 hours)
Secondary	Hours on mechanical ventilation.		30 days
Secondary	Hours on mechanical circulatory support.		30 days
Secondary	Hours on postoperative renal replacement therapy.		30 days
Secondary	End organ damage (kidney dysfunction).		30 days
Secondary	Change in total Sequential Organ Failure Assessment Score (SOFA).		30 days
Secondary	Amount of used resuscitation fluids.		30 days
Secondary	Amount of used blood transfusion products.		30 days
Secondary	Length of ICU stay.		30 days
Secondary	Length of hospital stay.		30 days
Secondary	30-Day hospital readmissions.		30 days
Secondary	All-cause mortality.		30 days