Prevention of Vasoplegia With the Use of CytoSorb.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Netherlands
Leiden University Medical Center
RECRUITING
Leiden
Contact Information
Primary
Olga Papazisi, MD
o.papazisi@lumc.nl
+31715264022
Backup
Eline F Bruggemans, MSc
e.f.bruggemans@lumc.nl
+31715264022
Time Frame
Start Date: 2021-10-27
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 36
Treatments
Active_comparator: CytoSorb-Yes
Heart failure patients that will receive intraoperative treatment with CytoSorb.
No_intervention: CytoSorb-No
Heart failure patients that will not receive intraoperative treatment with CytoSorb.
Related Therapeutic Areas
Sponsors
Leads: Leiden University Medical Center

This content was sourced from clinicaltrials.gov