European Registry for Hemadsorption in Sepsis With the Seraph Filter

Launched by CROATIAN SOCIETY FOR ORGAN SUPPORT · Oct 31, 2022

Keywords

ClinConnect Summary

This clinical trial, called the European Registry for Hemadsorption in Sepsis With the Seraph Filter, is studying a new blood purification method called the Seraph® 100 Microbind® Affinity Blood Filter. The goal is to find out if this filter can help patients in the intensive care unit (ICU) who are suffering from severe infections known as sepsis. Sepsis can lead to serious complications, including respiratory failure and multiple organ failure, and patients with this condition often face high risks of death in the hospital. The trial aims to identify which groups of septic patients might benefit the most from this treatment.

To be eligible for the trial, participants should be experiencing sepsis or septic shock, which means they have a serious infection that is affecting their body significantly. They should also show signs of severe inflammation and may require special medications to support their blood circulation. Other criteria include having respiratory issues that need mechanical help to breathe and being admitted to the ICU. If someone qualifies and decides to participate, they will be part of a study where researchers will closely monitor their health and response to the treatment to gather important information about its effectiveness. This trial is currently recruiting participants of all genders, aged 65 and older, to help improve care for patients with sepsis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sepsis or septic shock: sepsis is defined as the presence of suspected or documented infections along with systemic inflammatory response syndrome; septic shock is defined as the presence of sepsis and acute circulatory failure according to European criteria Society for Intensive Care Medicine
• • 2. laboratory and clinical evidence of systemic inflammation: high levels of inflammatory cytokines such as IL-6 (\>25 pg / ml); high values of inflammatory parameters from serum (leukocytes \>15x10 9 / l, CRP \>40 mg / l, procalcitonin \>0.9 mg / l) and a high SOFA score (\>2).
• • 3. clinical symptoms of hemodynamic instability requiring vasopressors
• • 4. diagnosis of ARDS
• • 5. deterioration of respiratory status with the onset of respiratory failure requiring mechanical ventilation (respiration rate \>30 / min, or oxygen saturation \<93%, or PaO2 / FiO2 ratio \<300mmHg).
• • 6. Admission to ICU
• Exclusion Criteria:
• • besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria