University Hospital Center Zagreb
Zagreb, City of Zagreb, 10000, Croatia
NCT Number: NCT05470907
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.
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Notify Me18 year and older
All sexes
Observational
Zagreb, City of Zagreb, 10000, Croatia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Commercial membranes for extracorporeal blood purification (hemoperfusion)
Time frame: 28 days
Define the inclusion criteria for extracorporeal blood purification (hemoperfusion) with different filters/hemadsorbers in ICU COVID-19 patients
Time frame: 24 hours after hemoperfusion initiation
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).
Time frame: 72 hours after finishing all the hemoperfusion procedures
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).
Time frame: 28 days
To assess the correlation between hemoperfusion and positive long-term outcome, defined as patient survival at ICU discharge.
Time frame: 24 hours after hemoperfusion initiation
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).
Time frame: 72 hours after finishing all the hemoperfusion procedures
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).
Time frame: 28 days
To assess the correlation between different filters/hemadsorbers and positive long-term outcome, defined as patient survival at ICU discharge.
Time frame: 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 (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Time frame: 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 short-term outcome (i.e. an improvement in hemodynamic stability, inflammatory status and respiratory status).
Time frame: 28 days
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).
Croatian Society for Organ Support
Other
South-Eastern Europe Registry for Hemoperfusion of Covid-19 ICU Patients
Acronym: HERICC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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