An observational study in Sepsis, Acute Respiratory Distress Syndrome and Infections - Pathogen Unspecified, sponsored by Croatian Society for Organ Support. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by Croatian Society for Organ Support · Observational
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.
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.
2,416 studies on the registry are indexed under Sepsis; 541 are open to participants now.
This study's planned enrollment of 300 is above the median of 150 across 1,162 observational studies indexed under Sepsis.
Browse Sepsis studies →Croatian Society for Organ Support is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
besides to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ICU septic patients treated with hemoperfusion
Device: Hemoperfusion
ICU septic patients non treated with hemoperfusion
Commercial membrane for extracorporeal blood purification (hemoperfusion)
Survival
Overall Survival after Seraph 100 therapy session
Time frame: 28 days
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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
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
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)
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
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)
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
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)
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
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)
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
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
Time frame: 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)
Time frame: 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)
Time frame: 72 hours after finishing the hemoperfusion procedure
Length of ICU stay
Time spend in the ICU after Seraph 100 therapy session
Time frame: 28 days
Length of Hospital stay
Time spend in the hospital after Seraph 100 therapy session
Time frame: 60 days
Adverse events
Report of any Seraph 100 therapy related adverse events
Time frame: 28 days
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2022 (actual). Primary completion is estimated for Jun 2023, 8 months after the start.
Of 491 non-industry observational studies under Sepsis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 58. This study's planned 8 months is below that.
Counting every sponsor, half of 543 studies reached it within 27 months; a quarter within 12 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
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Croatian Society for Organ Support