Registry for using the Seraph Filter in septic patients

European Registry for Hemadsorption of Septic Patients With the Seraph 100 Microbind Affinity Blood Filter (ASTREA Study)

This study is trying to see if the Seraph blood filter can help patients with severe infections in intensive care and which patients might benefit the most from it.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Croatian Society for Organ Support (other)
• Locations: 1 site (Zagreb, Grad Zagreb)
• Trial ID: NCT05608096 on ClinicalTrials.gov

What this trial studies

This observational registry aims to evaluate the effectiveness of the Seraph® 100 Microbind® Affinity Blood Filter in treating septic patients in intensive care units. It will collect data on patient outcomes and identify which groups of patients benefit most from hemadsorption therapy. The study seeks to establish clear inclusion criteria and treatment protocols based on the patients' clinical and laboratory characteristics. By analyzing a larger patient population, the registry hopes to provide more definitive conclusions about the efficacy of this treatment.

Who should consider this trial

Good fit: Ideal candidates include ICU patients diagnosed with sepsis or septic shock, exhibiting signs of systemic inflammation and respiratory failure.

Not a fit: Patients who do not meet the criteria for sepsis or septic shock, or those with contraindications to hemoperfusion, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates and better management strategies for patients suffering from sepsis and related conditions.

How similar studies have performed: Previous studies have shown promising results with hemadsorption techniques, but this registry aims to provide more robust data to confirm these findings.

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

Where this trial is running

Zagreb, Grad Zagreb

• University Hospital Center Zagreb — Zagreb, Grad Zagreb, Croatia (RECRUITING)

Study contacts

• Study coordinator: Vedran Premuzic, M.D., Ph.D.

Conditions: Sepsis, Acute Respiratory Distress Syndrome, Infections - Pathogen Unspecified, Disease, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome