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CompletedNCT05470907HERICCUpdated Feb 13, 2025

Registry for Hemoperfusion of Covid-19 ICU Patients

An observational study in COVID-19 Acute Respiratory Distress Syndrome, Viral Disease and Critical Illness, sponsored by Croatian Society for Organ Support. Completed at 1 site in Croatia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-13.

Sponsored by Croatian Society for Organ Support · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,050
Ages
18 Years and older
Sex
All
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Study summary

The ongoing COVID-19 pandemic caused high hospitalization and mortality rates especially in critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. The purpose of this registry study is to investigate the effectiveness and safety of the extracorporeal blood purification and hemoperfusion/hemadsorption filters in treating of critically ill COVID-19 patients.

Read the detailed description

The COVID-19 pandemic has been associated with high mortality rate and high percentage of patients with with severe multi-organ dysfunction. Many therapies were investigated in this group of patients. The usage of extracorporeal blood purification, namely hemoperfusion/hemadsorption was introduced in everyday clinical practice even before COVID-19 pandemic in which became increasingly common. The efficacy of hemoperfusion/hemadsorption in removal of endotoxins and cytokines is still questioned by some physicians mostly due to the fact that some trials failed to demonstrate the effect of this therapy on long-term outcomes of critically ill patients. Unfortunately, there is no present study with a large number of patients that would offer us clear answers on the treatment of ICU COVID-19 patients with adsorption filters, extracorporeal methods and the hemoperfusion method. Several extracorporeal blood purification therapies have been proposed to attenuate systemic inflammation in COVID-19 patients but there is no study which analyzed more than one filter or patients without specific conditions. Due to these limitations the studies were not able to analyze the method itself. Therefore, the primary aim of this observational prospective, multi-centric, regional web-based registry is to define the results and outcome of treatment, possible advantages over patients who have not undergone targeted treatment and to set regional indications/inclusion criteria for the treatment of ICU COVID-19 patients with the method of hemoadsorption/hemoperfusion.

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Conditions studied

  • COVID-19 Acute Respiratory Distress Syndrome
  • Viral Disease
  • Critical Illness
  • Multi Organ Failure
  • Systemic Inflammatory Response Syndrome
  • AKI - Acute Kidney Injury

Keywords

  • COVID-19 Acute Respiratory Distress Syndrome
  • Viral Disease
  • Critical Illness
  • Multi Organ Failure
  • Systemic Inflammatory Response Syndrome
  • AKI - Acute Kidney Injury
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In context

Virus Diseases

927 studies on the registry are indexed under Virus Diseases; 112 are open to participants now.

This study's enrollment of 1,050 is above the median of 311 across 278 observational studies indexed under Virus Diseases.

Browse Virus Diseases studies →

Lead sponsor

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.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

All medical institutions from South-East European countries (Slovenia, Croatia, Bosnia, Montenegro, Serbia, Macedonia, Albania, Kosovo, Greece, Italy, Turkey, Bulgaria and Romania) that provide extracorporeal blood purification treatments to COVID-19 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.

Inclusion criteria

  1. COVID-19 infection
  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. diagnosed with 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
  4. clinical symptoms of hemodynamic instability requiring vasopressors and initial signs immune dysregulation or cascade coagulation disorders
  5. acute kidney injury assessed according to KDIGO / AKIN criteria: increase in serum creatinine ≥ 0.3 mg / dL within 48 hours, or ≥ 50% over 7 days, or hourly diuresis \<0.5 mL / kg / h for more than 6 hours
  6. diagnosis of ARDS
  7. the need for ECMO
  8. 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).
  9. Admission to ICU

Exclusion criteria

Exclusion Criteria:

  • besides contraindications to the use of the hemoperfusion adopted (as from the manual of instructions), there are no exclusion criteria
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,050 participants (actual)
Target follow-up
28 Days
Patient registry
Yes

Groups and cohorts

  • EBP

    ICU COVID-19 patients treated with hemoperfusion/hemadsorption

    Device: Hemoperfusion

  • non-EBP

    ICU COVID-19 patients not treated with hemoperfusion/hemadsorption

Interventions

  • DeviceHemoperfusion

    Commercial membranes for extracorporeal blood purification (hemoperfusion)

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What researchers measure

Primary outcomes

  1. Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients

    Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with different filters/hemadsorbers in ICU COVID-19 patients

    Time frame: 28 days

Secondary outcomes

  1. 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, inflammatory status and respiratory status).

    Time frame: 24 hours after hemoperfusion initiation

  2. 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, inflammatory status and respiratory status).

    Time frame: 72 hours after finishing all the hemoperfusion procedures

  3. To assess the correlation between hemoperfusion and positive long-term outcome

    To assess the correlation between hemoperfusion and positive long-term outcome, defined as patient survival at ICU discharge.

    Time frame: 28 days

  4. To assess the correlation between different filters/hemadsorbers and positive short-term outcome

    Define as to assess the correlation between different filters/hemadsorbers and positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).

    Time frame: 24 hours after hemoperfusion initiation

  5. To assess the correlation between different filters/hemadsorbers and positive short-term outcome

    Define as to assess the correlation between different filters/hemadsorbers and positive long-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).

    Time frame: 72 hours after finishing all the hemoperfusion procedures

  6. To assess the correlation between different filters/hemadsorbers and positive long-term outcome

    To assess the correlation between different filters/hemadsorbers and positive long-term outcome, defined as patient survival at ICU discharge.

    Time frame: 28 days

  7. The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome

    The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).

    Time frame: 24 hours after initiation of the procedure with the combination of filters/hemadsorbers and extracorporeal organ support therapy

  8. The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome

    The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).

    Time frame: 72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy

  9. The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome

    The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).

    Time frame: 28 days

07

Study locations

1 site
  • University Hospital Center Zagreb
    Zagreb, City of Zagreb 10000, Croatia
08

References and documents

Publications

  • Lovric D, Situm I, Nedeljkovic V, Mogus M, Erceg A, Mazar M, Mihaljevic S, Premuzic V. Seraph(R) filter effectiveness in the treatment of circuit-related infections in ECMO patients-a single-center report. Front Med (Lausanne). 2025 Oct 17;12:1664552. doi: 10.3389/fmed.2025.1664552. eCollection 2025. PubMed 41179859 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2022 to primary completion in Feb 2025, 30 months.

Of 120 non-industry observational studies under Virus Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 48. This study's 30 months is above that.

Counting every sponsor, half of 140 studies reached it within 21 months; a quarter within 10 and three quarters within 45.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 21, 2022
First posted
Jul 22, 2022
StartActual
Jul 21, 2022
Primary completionActual
Feb 1, 2025
CompletionActual
Feb 5, 2025
Last update
Feb 13, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05470907
Lead sponsor
Croatian Society for Organ Support
Collaborators
Clinical Hospital Centre Zagreb
Responsible party
Vedran Premuzic (Principal Investigator, Croatian Society for Organ Support) — Principal investigator
First posted
Jul 22, 2022
Start date
Jul 21, 2022
Primary completion
Feb 1, 2025
Completion
Feb 5, 2025
Last update
Feb 13, 2025

Study contacts

Vedran Premuzic, M.D., Ph.D.
principal investigator · Clinical Hospital Centre Zagreb

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

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