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

NCT04812717 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2023-12-13

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

CytoSorb device

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

Sponsors & Collaborators

  • Leiden University Medical Center

    lead OTHER

Principal Investigators

  • Meindert Palmen, MD, PhD · Leiden University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2025-12-31
Completion
2026-01-31

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04812717 on ClinicalTrials.gov