Critical Illness Clinical Trial
— HERICCOfficial title:
South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
Verified date | February 2024 |
Source | Croatian Society for Organ Support |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Enrolling by invitation |
Enrollment | 300 |
Est. completion date | September 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Croatia | University Hospital Center Zagreb | Zagreb | Grad Zagreb |
Lead Sponsor | Collaborator |
---|---|
Croatian Society for Organ Support | Clinical Hospital Centre Zagreb |
Croatia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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). | 24 hours after hemoperfusion initiation | |
Secondary | 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). | 72 hours after finishing all the hemoperfusion procedures | |
Secondary | 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. | 28 days | |
Secondary | 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). | 24 hours after hemoperfusion initiation | |
Secondary | 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). | 72 hours after finishing all the hemoperfusion procedures | |
Secondary | 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. | 28 days | |
Secondary | 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). | 24 hours after initiation of the procedure with the combination of filters/hemadsorbers and extracorporeal organ support therapy | |
Secondary | 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). | 72 hours after finishing all the procedures with the combination of filters/hemadsorbers and extracorporeal organ support therapy | |
Secondary | 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). | 28 days |
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