Registry for Hemoperfusion of Covid-19 ICU Patients

NCT05470907 | Completed FDA Device

• 1 other identifier: HERICC-1982
• Study Type: observational
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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

  28 days

Secondary Outcomes (9)

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

  24 hours after hemoperfusion initiation

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

  72 hours after finishing all the hemoperfusion procedures

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

  28 days

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

  24 hours after hemoperfusion initiation

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

  72 hours after finishing all the hemoperfusion procedures

Study Arms (2)

EBP

ICU COVID-19 patients treated with hemoperfusion/hemadsorption

Device: Hemoperfusion

non-EBP

ICU COVID-19 patients not treated with hemoperfusion/hemadsorption

Interventions

Hemoperfusion DEVICE

Commercial membranes for extracorporeal blood purification (hemoperfusion)

EBP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• COVID-19 infection
• 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).
• 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
• clinical symptoms of hemodynamic instability requiring vasopressors and initial signs immune dysregulation or cascade coagulation disorders
• 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
• diagnosis of ARDS
• the need for ECMO
• 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

Location

Related Publications (1)

• 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.

  PMID: 41179859 DERIVED

MeSH Terms

Conditions

Virus Diseases; Critical Illness; Multiple Organ Failure; Systemic Inflammatory Response Syndrome; Acute Kidney Injury

Interventions

Hemoperfusion

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Inflammation; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Vedran Premuzic, M.D., Ph.D.

  Clinical Hospital Centre Zagreb

  PRINCIPAL INVESTIGATOR

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: July 21, 2022
• First Posted: July 22, 2022
• Study Start: July 21, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 5, 2025
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)