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European Registry for Hemadsorption in Sepsis With the Seraph Filter

Croatia300 participantsStarted 2022-10-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 Medicine
✓. 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).
✓. clinical symptoms of hemodynamic instability requiring vasopressors
✓. diagnosis of ARDS
✓. 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).
✓. Admission to ICU

What they're measuring

Survival

Timeframe: 28 days

Trial details

NCT IDNCT05608096

SponsorCroatian Society for Organ Support

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-30

Contact for this trial

Vedran Premuzic, M.D., Ph.D.

+385915274778 vpremuzic@gmail.com

View on ClinicalTrials.gov More Sepsis trials