Registry for Hemoperfusion of Covid-19 ICU Patients

NCT ID: NCT05470907

Last Updated: 2025-02-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1050 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2025-02-05

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Viral Disease; Critical Illness; Multi Organ Failure; Systemic Inflammatory Response Syndrome; AKI - Acute Kidney Injury

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

EBP

ICU COVID-19 patients treated with hemoperfusion/hemadsorption

Hemoperfusion

Intervention Type: DEVICE

Commercial membranes for extracorporeal blood purification (hemoperfusion)

non-EBP

ICU COVID-19 patients not treated with hemoperfusion/hemadsorption

No interventions assigned to this group

Interventions

Hemoperfusion

Commercial membranes for extracorporeal blood purification (hemoperfusion)

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Hospital Centre Zagreb

OTHER

Sponsor Role: collaborator

Croatian Society for Organ Support

OTHER

Sponsor Role: lead

Responsible Party

Vedran Premuzic

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vedran Premuzic, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Clinical Hospital Centre Zagreb

Locations

University Hospital Center Zagreb

Zagreb, City of Zagreb, Croatia

Countries

Croatia

Other Identifiers

HERICC-1982

Identifier Type: -

Identifier Source: org_study_id