Registry for Hemoperfusion of Covid-19 ICU Patients (HERICC)

South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients

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.

Study Overview

• Status: Completed
• Conditions: Systemic Inflammatory Response Syndrome; Critical Illness; Multi Organ Failure; COVID-19 Acute Respiratory Distress Syndrome; Viral Disease; AKI - Acute Kidney Injury
• Intervention / Treatment: Device: Hemoperfusion

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.

• Study Type: Observational
• Enrollment (Actual): 1050

Contacts and Locations

Study Locations

• Croatia
  • Grad Zagreb
    • Zagreb, Grad Zagreb, Croatia, 10000
      • University Hospital Center Zagreb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EBP; ICU COVID-19 patients treated with hemoperfusion/hemadsorption	Device: Hemoperfusion; Commercial membranes for extracorporeal blood purification (hemoperfusion)
non-EBP; ICU COVID-19 patients not treated with hemoperfusion/hemadsorption

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Croatian Society for Organ Support
• Collaborators: Clinical Hospital Centre Zagreb
• Investigators: Principal Investigator: Vedran Premuzic, M.D., Ph.D., Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 5, 2025

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: July 21, 2022
• First Posted (Actual): July 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 11, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Critical Illness; Systemic Inflammatory Response Syndrome; Viral Disease; Multi Organ Failure; COVID-19 Acute Respiratory Distress Syndrome; AKI - Acute Kidney Injury
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Respiratory Tract Diseases; Disease; Inflammation; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Renal Insufficiency; Shock; Lung Injury; COVID-19; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Critical Illness; Acute Kidney Injury; Virus Diseases; Multiple Organ Failure; Acute Lung Injury; Systemic Inflammatory Response Syndrome
• Other Study ID Numbers: HERICC-1982

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes