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Search / Trial NCT04812717

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

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Mar 20, 2021

Trial Information

Current as of August 25, 2025

Recruiting

Keywords

Heat Failure Vasoplegia Cardiopulmonary Bypass Systemic Inflammatory Response Syndrome

ClinConnect Summary

This clinical trial is studying a device called CytoSorb, which is designed to help prevent low blood pressure, known as vasoplegia, after heart surgery in patients with heart failure. Vasoplegia can happen when the blood vessels don't work properly after surgery, often due to the heart-lung machine used during the procedure. The CytoSorb filter aims to reduce the immune system's response to the artificial environment created by the heart-lung machine, potentially leading to better blood pressure control after surgery.

To participate in this trial, patients must be at least 18 years old, diagnosed with heart failure, and have a specific heart function measurement indicating their condition. They should also be scheduled for a planned cardiac surgery that will last longer than two hours. The study is currently recruiting participants and is open to all genders. If you or a loved one meets these criteria, joining the trial may offer a chance to improve outcomes after heart surgery. Participants can expect to be monitored closely during and after the procedure, and their experiences will help researchers understand the benefits of using the CytoSorb filter.

Gender

ALL

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.

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Leiden, , Netherlands

Patients applied

0 patients applied

Trial Officials

Meindert Palmen, MD, PhD

Principal Investigator

Leiden University Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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