Using a filter to prevent low blood pressure after heart surgery in heart failure patients

Prevention of Vasoplegia With the Use of CytoSorb.

This study is testing if using a special filter during heart surgery can help prevent low blood pressure in patients with heart failure.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Leiden University Medical Center (Academic / other)
• Locations: 1 site (Leiden)
• Trial ID: NCT04812717 on ClinicalTrials.gov

What this trial studies

This study investigates the use of the CytoSorb device, a filter integrated into the heart-lung machine, to reduce the immune response during cardiac surgery for patients with heart failure. Vasoplegia, a condition characterized by low blood pressure after surgery, is a common complication that can lead to poor outcomes. The study aims to determine if minimizing the systemic inflammatory response syndrome (SIRS) can decrease the incidence of vasoplegia in these patients. It is a single-center, investigator-initiated study focusing on the efficacy and cost-effectiveness of this intervention.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with heart failure, specifically with a left ventricular ejection fraction of 35% or less, who are scheduled for cardiac surgery requiring cardiopulmonary bypass.

Not a fit: Patients who are incapacitated, require emergency surgery, or have severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the occurrence of vasoplegia, improving recovery and outcomes for heart failure patients undergoing surgery.

How similar studies have performed: While the use of filters in cardiac surgery is a novel approach, similar studies have shown promise in reducing complications associated with systemic inflammatory responses.

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.

Where this trial is running

Leiden

• Leiden University Medical Center — Leiden, Netherlands (Recruiting)

Study contacts

• Principal investigator: Meindert Palmen, MD, PhD — Leiden University Medical Center
• Study coordinator: Olga Papazisi, MD

Conditions Heart Failure; Vasoplegia; Heat Failure; Cardiopulmonary Bypass; Systemic Inflammatory Response Syndrome