European Registry for Hemadsorption in Sepsis With the Seraph Filter

Croatian Society for Organ Support

Status: Enrolling

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

Treatments: Device: Hemoperfusion

Study type: Observational

Funder types: Other

Identifiers

NCT05608096

ASTREA-1982

Details and patient eligibility

About

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.

Full description

Hemadsorption was introduced in everyday clinical practice before the COVID-19 pandemic. The efficacy of hemadsorption removal of endotoxins and cytokines is still, by some, controversial due to the fact that most of the studies were performed in a small number of patients with very different diagnoses, comorbidities and disease severity. Furthemore, some studies enrolled patients over a prolonged period of time with very high SOFA scores and multi-organ failure where it is difficult to expect any significant effect of any kind of organ support therapy. The COSA registry reported that the treatment of COVID-19 patients with Seraph 100 was well tolerated and observed lower mortality in the registry when compared to calculated mortality.

The primary aim of this observational prospective, multi-center, multistate web-based registry is to define the effectiveness and outcome of Seraph 100 treatment(s), investigate possible advantages of early targeted treatment and to set indications/inclusion criteria for the treatment of ICU septic patients with the method of hemoadsorption.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Hemoperfusion

Description:

ICU septic patients treated with hemoperfusion

Treatment:

Device: Hemoperfusion

non-hemoperfusion

Description:

ICU septic patients non treated with hemoperfusion