Clinical trial NCT05608096: European Registry for Hemadsorption in Sepsis With the Seraph Filter
Official title: European Registry for Hemadsorption of Septic Patients With the Seraph 100 Microbind Affinity Blood Filter (ASTREA Study)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sepsis
Acute Respiratory Distress Syndrome
Infections - Pathogen Unspecified
Disease
Critical Illness
Multi Organ Failure
Systemic Inflammatory Response Syndrome
Keywords: Acute Respiratory Distress Syndrome
Sepsis
Critical Illness
Multi Organ Failure
Systemic Inflammatory Response Syndrome
Lead sponsor: Croatian Society for Organ Support
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
First posted: 2022-11-08
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All medical institutions from European countries (Croatia, Finland, Germany, Italy, France, Greece, Slovenia) that provide extracorporeal blood purification treatments to septic critically ill patients are eligible for participation.

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: Survival
timeFrame: 28 days
Secondary outcomes:
measure: Define the inclusion criteria for hemoperfusion with Seraph 100 in ICU septic patients
timeFrame: 28 days
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: Immediately after first hemoperfusion procedure
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: Immediately after first hemoperfusion procedure
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: 72 hours after finishing the hemoperfusion procedure
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: 72 hours after finishing the hemoperfusion procedure
measure: To assess the correlation between hemoperfusion and positive long-term outcome
timeFrame: 28 days
measure: The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: Immediately after first hemoperfusion procedure in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT)
measure: The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: Immediately after first hemoperfusion procedure in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT)
measure: The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: 72 hours after finishing the procedures with the combination of hemoperfusion and extracorporeal organ support therapy
measure: The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: 72 hours after finishing the procedures with the combination of hemoperfusion and extracorporeal organ support therapies (i.e. ECMO, CRRT)
measure: The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome
timeFrame: 28 days
measure: To assess the correlation between hemoperfusion and negative short-term outcome
timeFrame: Immediately after first hemoperfusion procedure
measure: To assess the correlation between hemoperfusion and negative short-term outcome
timeFrame: 72 hours after finishing the hemoperfusion procedure
measure: Length of ICU stay
timeFrame: 28 days
measure: Length of Hospital stay
timeFrame: 60 days
measure: Adverse events
timeFrame: 28 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: Grad Zagreb
Study officials:
References: