European Registry for Hemadsorption in Sepsis With the Seraph Filter

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sepsis; Systemic Inflammatory Response Syndrome; Disease; Critical Illness; Acute Respiratory Distress Syndrome; Multi Organ Failure; Infections - Pathogen Unspecified
• Intervention / Treatment: Device: Hemoperfusion

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.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • Recruiting
      • University Hospital Center Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemoperfusion; ICU septic patients treated with hemoperfusion	Device: Hemoperfusion; Commercial membrane for extracorporeal blood purification (hemoperfusion)
non-hemoperfusion; ICU septic patients non treated with hemoperfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	Overall Survival after Seraph 100 therapy session	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Define the inclusion criteria for hemoperfusion with Seraph 100 in ICU septic patients	Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with Seraph 100 in ICU septic patients	28 days
To assess the correlation between hemoperfusion and positive short-term outcome	Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in hemodynamic stability and respiratory status will be combined to report SOFA score)	Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome	Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in inflammatory status)	Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome	Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in hemodynamic stability and respiratory status will be combined to report SOFA score)	72 hours after finishing the hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome	Define as to assess the correlation between hemoperfusion and positive short-term outcome (i.e. an improvement in inflammatory status)	72 hours after finishing the hemoperfusion procedure
To assess the correlation between hemoperfusion and positive long-term outcome	Define as to assess the correlation between hemoperfusion and positive long-term outcome, defined as patient survival at ICU discharge	28 days
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome	Define as to assess the effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. improvement in hemodynamic stability and respiratory status will be combined to report SOFA score)	Immediately after first hemoperfusion procedure in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT)
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome	Define as to assess the effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. improvement in inflammatory status)	Immediately after first hemoperfusion procedure in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT)
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome	Define as to assess the effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. an improvement in hemodynamic stability and respiratory status will be combined to report SOFA score)	72 hours after finishing the procedures with the combination of hemoperfusion and extracorporeal organ support therapy
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome	Define as to assess the effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. improvement in inflammatory status)	72 hours after finishing the procedures with the combination of hemoperfusion and extracorporeal organ support therapies (i.e. ECMO, CRRT)
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome	The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome, defined as patient survival at ICU discharge	28 days
To assess the correlation between hemoperfusion and negative short-term outcome	Define as to assess the correlation between hemoperfusion and negative short-term outcome (i.e. initial signs of humoral immune dysregulation (hypogammaglobulinemia defined as a gamma-globulin fraction below 10%) or cascade coagulation disorders (severe thrombocytopenia <15,000 cells/uL or severe bleeding)	Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and negative short-term outcome	Define as to assess the correlation between hemoperfusion and negative short-term outcome (i.e. initial signs of humoral immune dysregulation (hypogammaglobulinemia defined as a gamma-globulin fraction below 10%) or cascade coagulation disorders (severe thrombocytopenia <15,000 cells/uL or severe bleeding)	72 hours after finishing the hemoperfusion procedure
Length of ICU stay	Time spend in the ICU after Seraph 100 therapy session	28 days
Length of Hospital stay	Time spend in the hospital after Seraph 100 therapy session	60 days
Adverse events	Report of any Seraph 100 therapy related adverse events	28 days

Collaborators and Investigators

• Sponsor: Croatian Society for Organ Support
• Collaborators: Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): December 30, 2025

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: October 31, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: October 31, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Sepsis; Critical Illness; Acute Respiratory Distress Syndrome; Systemic Inflammatory Response Syndrome; Multi Organ Failure
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Inflammation; Disease Attributes; Disease; Infant, Newborn, Diseases; Shock; Lung Injury; Infant, Premature, Diseases; Sepsis; Syndrome; Critical Illness; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Systemic Inflammatory Response Syndrome; Multiple Organ Failure
• Other Study ID Numbers: ASTREA-1982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes