European Registry for Hemadsorption in Sepsis With the Seraph Filter

NCT05608096 | Unknown FDA Device

• 1 other identifier: ASTREA-1982
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Survival

  Overall Survival after Seraph 100 therapy session

  28 days

Secondary Outcomes (16)

• Define the inclusion criteria for hemoperfusion with Seraph 100 in ICU septic patients

  28 days

• To assess the correlation between hemoperfusion and positive short-term outcome

  Immediately after first hemoperfusion procedure

• To assess the correlation between hemoperfusion and positive short-term outcome

  Immediately after first hemoperfusion procedure

• To assess the correlation between hemoperfusion and positive short-term outcome

  72 hours after finishing the hemoperfusion procedure

• To assess the correlation between hemoperfusion and positive short-term outcome

  72 hours after finishing the hemoperfusion procedure

Study Arms (2)

Hemoperfusion

ICU septic patients treated with hemoperfusion

Device: Hemoperfusion

non-hemoperfusion

ICU septic patients non treated with hemoperfusion

Interventions

Hemoperfusion DEVICE

Commercial membrane for extracorporeal blood purification (hemoperfusion)

Hemoperfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Croatian Society for Organ Support: lead
• Clinical Hospital Centre Zagreb: collaborator

Study Sites (1)

University Hospital Center Zagreb

Zagreb, City of Zagreb, 10000, Croatia

RECRUITING

MeSH Terms

Conditions

Sepsis; Respiratory Distress Syndrome; Disease; Critical Illness; Multiple Organ Failure; Systemic Inflammatory Response Syndrome

Interventions

Hemoperfusion

Condition Hierarchy (Ancestors)

Infections; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Disease Attributes; Shock

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Central Study Contacts

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

CONTACT

+385915274778; vpremuzic@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 8, 2022
• Study Start: October 25, 2022
• Primary Completion: June 30, 2023
• Study Completion: December 30, 2025
• Last Updated: November 8, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)