Clinical trial NCT05470907: Registry for Hemoperfusion of Covid-19 ICU Patients
Official title: South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Croatian Society for Organ Support
Sponsor class: OTHER
Collaborators: name: Clinical Hospital Centre Zagreb
First posted: 2022-07-22
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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:

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

Primary outcomes:
measure: Define the inclusion criteria for hemoperfusion in ICU COVID-19 patients
timeFrame: 28 days
Secondary outcomes:
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: 24 hours after hemoperfusion initiation
measure: To assess the correlation between hemoperfusion and positive short-term outcome
timeFrame: 72 hours after finishing all the hemoperfusion procedures
measure: To assess the correlation between hemoperfusion and positive long-term outcome
timeFrame: 28 days
measure: To assess the correlation between different filters/hemadsorbers and positive short-term outcome
timeFrame: 24 hours after hemoperfusion initiation
measure: To assess the correlation between different filters/hemadsorbers and positive short-term outcome
timeFrame: 72 hours after finishing all the hemoperfusion procedures
measure: To assess the correlation between different filters/hemadsorbers and positive long-term outcome
timeFrame: 28 days
measure: The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: 24 hours after initiation of the procedure with the combination of filters/hemadsorbers and extracorporeal organ support therapy
measure: The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive short-term outcome
timeFrame: 72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy
measure: The effects of filters/hemadsorbents in combination with other extracorporeal organ support therapies (i.e. ECMO, CRRT) on positive long-term outcome
timeFrame: 28 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
state: Grad Zagreb
Study officials:
affiliation: Clinical Hospital Centre Zagreb
name: Vedran Premuzic, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: