SepsisNCT05608096
European Registry for Hemadsorption in Sepsis With the Seraph Filter
An observational study of Sepsis and Acute Respiratory Distress Syndrome, run by Croatian Society for Organ Support at 1 site in Croatia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Acute Respiratory Distress Syndrome, Infections - Pathogen Unspecified
- What is being tested?
- Hemoperfusion
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteCroatia
- Study dates
- 25 Oct 2022to 30 Dec 2025
- How long will I take part?
- 28 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Trial locations and contacts
1 site in 1 country.
Croatia1 site, 1 recruiting
- Recruiting
University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000
Vedran Premuzic, M.D., Ph.D., +385915274778, vpremuzic@gmail.com
Vedran Premuzic, M.D., Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sepsis, Acute Respiratory Distress Syndrome, Infections - Pathogen Unspecified, Disease, Critical Illness, Multi Organ Failure
- Being tested
- Hemoperfusion
- Keywords
- Acute Respiratory Distress Syndrome, Sepsis, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome
- Medical subject headings
- Sepsis, Respiratory Distress Syndrome, Disease, Critical Illness, Multiple Organ Failure, Systemic Inflammatory Response Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemoperfusionDevice
Commercial membrane for extracorporeal blood purification (hemoperfusion)
| Study group | Role | What they receive |
|---|---|---|
| Hemoperfusion | ICU septic patients treated with hemoperfusion Receives: Device: Hemoperfusion | |
| non-hemoperfusion | ICU septic patients non treated with hemoperfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Overall Survival after Seraph 100 therapy session
Measured: 28 days
Secondary outcomes (16)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 72 hours after finishing the hemoperfusion procedure
Length of ICU stay
Time spend in the ICU after Seraph 100 therapy session
Measured: 28 days
Length of Hospital stay
Time spend in the hospital after Seraph 100 therapy session
Measured: 60 days
Adverse events
Report of any Seraph 100 therapy related adverse events
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2022
- Study start25 Oct 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Croatian Society for Organ Support
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Responsible party
- Principal investigator, Vedran Premuzic, Croatian Society for Organ Support
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05608096
- Sponsor's protocol ID
- ASTREA-1982
- Status last verified
- Oct 2022
- First submitted
- 26 Oct 2022
- Last updated
- 8 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Registry for Hemadsorption of Septic Patients With the Seraph 100 Microbind Affinity Blood Filter (ASTREA Study)
- ClinicalTrials.gov ID
- NCT05608096
- Acronym / sponsor ID
- ASTREA-1982
- Conditions
- Sepsis, Acute Respiratory Distress Syndrome, Infections - Pathogen Unspecified, Disease, Critical Illness, Multi Organ Failure
- Keywords
- Acute Respiratory Distress Syndrome, Sepsis, Critical Illness, Multi Organ Failure, Systemic Inflammatory Response Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Croatian Society for Organ SupportUniversity, hospital or other
- Collaborators
- Clinical Hospital Centre Zagreb
- Study start
- 25 Oct 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 8 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoperfusion | – | Device: HemoperfusionICU septic patients treated with hemoperfusion |
| non-hemoperfusion | – | –ICU septic patients non treated with hemoperfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (1 listed)
- besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoperfusionCommercial membrane for extracorporeal blood purification (hemoperfusion) | Device | Hemoperfusion |
Primary outcome
Survival
Time frame: 28 days
Overall Survival after Seraph 100 therapy session
16 secondary outcomes
Define the inclusion criteria for hemoperfusion with Seraph 100 in ICU septic patients
Time frame: 28 days
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: 72 hours after finishing the hemoperfusion procedure
To assess the correlation between hemoperfusion and positive short-term outcome
Time frame: 72 hours after finishing the hemoperfusion procedure
To assess the correlation between hemoperfusion and positive long-term outcome
Time frame: 28 days
The effects of hemoperfusion in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 28 days
To assess the correlation between hemoperfusion and negative short-term outcome
Time frame: Immediately after first hemoperfusion procedure
To assess the correlation between hemoperfusion and negative short-term outcome
Time frame: 72 hours after finishing the hemoperfusion procedure
Length of ICU stay
Time frame: 28 days
Length of Hospital stay
Time frame: 60 days
Adverse events
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Acute Respiratory Distress Syndrome, run by Croatian Society for Organ Support at 1 site in Croatia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Croatia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vedran Premuzic, M.D., Ph.D. (+385915274778, vpremuzic@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2022.