PREVENTION OF VASOPLEGIA WITH THE USE OF CYTOSORB

PREVENTION OF VASOPLEGIA WITH THE USE OF CYTOSORB - CytoSorb-HF Trial

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55069

Enrollment

Registered

2020-03-30

Start date

2021-10-27

Completion date

Unknown

Last updated

2026-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vasoplegia Low blood pressure

Interventions

The investigational treatment that the patients randomized for CytoSorb treatment will receive includes the use of the CytoSorb device in the CPB circuit .

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Diagnosed with heart failure (HF) in line with the European Society of Cardiology (ESC) guidelines -Left ventricular ejection fraction (EF) = 18 years.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
- Change in systemic vascular resistance index after phenylephrine administration (delta SVRi) after CPB; - Reduction in the occurrence of Vasoplegic Syndrome (VS).	—

Secondary

Measure	Time frame
Secondary study parameters: - Delta SVRi in ICU; - Total dose of vasopressors administered; - Change in IL-6, IL-8, IL-10 levels; - Change in sublingual microcirculation; - Change in MAP after phenylephrine administration; - Hours on mechanical ventilation; - Hours on mechanical circulatory support; - Hours on postoperative renal replacement therapy; - End-organ damage (kidney dysfunction); - Change in total Sequential Organ Failure Assessment Score (SOFA); - Amount of used blood transfusion products; - Amount of used resuscitation fluids; - Length of Intensive Care Unit (ICU) stay; - Length of the hospital stay; - 30-Day hospital readmissions; - All-cause mortality. Cost effectiveness parameters: - Total administered dosage of vasopressors; - Amount of used blood transfusion products; - Amount of used resuscitation fluids; - Duration of surgery; - Length of ICU stay; - Length of the hospital stay; - Hospital readmissions.	—

Measure

Time frame

Secondary study parameters: - Delta SVRi in ICU; - Total dose of vasopressors administered; - Change in IL-6, IL-8, IL-10 levels; - Change in sublingual microcirculation; - Change in MAP after phenylephrine administration; - Hours on mechanical ventilation; - Hours on mechanical circulatory support; - Hours on postoperative renal replacement therapy; - End-organ damage (kidney dysfunction); - Change in total Sequential Organ Failure Assessment Score (SOFA); - Amount of used blood transfusion products; - Amount of used resuscitation fluids; - Length of Intensive Care Unit (ICU) stay; - Length of the hospital stay; - 30-Day hospital readmissions; - All-cause mortality. Cost effectiveness parameters: - Total administered dosage of vasopressors; - Amount of used blood transfusion products; - Amount of used resuscitation fluids; - Duration of surgery; - Length of ICU stay; - Length of the hospital stay; - Hospital readmissions.

—

Countries

Netherlands

Contacts

Public ContactO Papazisi

Leids Universitair Medisch Centrum

o.papazisi@lumc.nl+31715264022

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Apr 17, 2026