Registry for Hemoperfusion of Covid-19 ICU Patients

Last updated: February 11, 2025
Sponsor: Croatian Society for Organ Support
Overall Status: Completed

Phase

N/A

Condition

Covid-19

Lung Injury

Respiratory Failure

Treatment

Hemoperfusion

Clinical Study ID

NCT05470907
HERICC-1982
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. COVID-19 infection

  2. laboratory and clinical evidence of systemic inflammation: high levels ofinflammatory cytokines such as IL-6 (>25 pg / ml); high values of inflammatoryparameters from serum (leukocytes >15x10 9 / l, CRP >40 mg / l, procalcitonin >0.9mg / l) and a high SOFA score (>2).

  3. diagnosed with sepsis or septic shock: sepsis is defined as the presence ofsuspected or documented infections along with systemic inflammatory responsesyndrome; septic shock is defined as the presence of sepsis and acute circulatoryfailure according to European criteria Society for Intensive Care Medicine

  4. clinical symptoms of hemodynamic instability requiring vasopressors and initialsigns immune dysregulation or cascade coagulation disorders

  5. acute kidney injury assessed according to KDIGO / AKIN criteria: increase in serumcreatinine ≥ 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 requiringmechanical ventilation (respiration rate >30 / min, or oxygen saturation <93%, orPaO2 / FiO2 ratio <300mmHg).

  9. Admission to ICU

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 1050
Treatment Group(s): 1
Primary Treatment: Hemoperfusion
Phase:
Study Start date:
July 21, 2022
Estimated Completion Date:
February 05, 2025

Study 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.

Connect with a study center

  • University Hospital Center Zagreb

    Zagreb, Grad Zagreb 10000
    Croatia

    Site Not Available

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