NCT05470907

Registry for Hemoperfusion of Covid-19 ICU Patients

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,050 (actual)
• Sponsor: Croatian Society for Organ Support · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Hemoperfusion	Commercial membranes for extracorporeal blood purification (hemoperfusion)

Timeline

• Start date: 2022-07-21
• Primary completion: 2025-02-01
• Completion: 2025-02-05
• First posted: 2022-07-22
• Last updated: 2025-02-13

Locations

1 site across 1 country: Croatia

Regulatory

• FDA-regulated device study