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Recruiting
NCT05608096
European Registry for Hemadsorption in Sepsis With the Seraph Filter
Conditions: Sepsis, Acute Respiratory Distress Syndrome, Infections - Pathogen Unspecified, Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome
Sex: All
Ages: 18 Years – N/A
Enrollment: 300
Sponsor: Croatian Society for Organ Support
Location: Croatia
Summary
Although new techniques like extracorporeal blood purification have lately emerged, septic patients still have very high hospital mortality rates.
Sepsis can be induced by either viremia, bacteriemia or in some cases both.
Many studies have reported the effectiveness of different hemadsorbers, but patient sample sizes have been inadequate for definitive conclusions.
Secondly, there are still no clear inclusion criteria as well as criteria for when to cease hemadsorption mostly due to immune dysregulation or cascade coagulation disorders.
The aim of this observational prospective registry is to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) in the treatment of septic ICU patients and to evaluate which cluster of these patients should benefit most with this therapy.
Eligibility Criteria
Inclusion Criteria: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 Medicinelaboratory 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).clinical symptoms of hemodynamic instability requiring vasopressorsdiagnosis of ARDSdeterioration 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).Admission to ICUExclusion Criteria:besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Source: ClinicalTrials.gov (NCT05608096). StuddyBuddy aggregates publicly available trial information.