Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179771
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2023-10-09
Brief Title:
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support
Sponsor:
University Hospitals Leicester
Organization:
University Hospitals Leicester
Study Overview
Official Title:
HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support for Acute Critical Illness a Prospective Randomised Interventional Feasibility Pilot Study HACEC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HACEC
Brief Summary:
Patients who are very ill either due to a severe infection major organ injury trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation ECMO for the heart and lungs This is often due to a reaction of the body to the insult which is termed inflammation The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit The investigators want to assess the feasibility of conducting a study with the HA380 column We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO time spent on the breathing machine time spent requiring drugs to support blood pressure and time spent in the intensive care unit
Detailed Description:
The role of inflammation in the pathophysiology of major organ dysfunction in critically ill patients is well established and this correlates with the degree of organ dysfunction which consequently may require increased level of organ support in the intensive care unit Critically ill patients present in a spectrum of inflammatory states and on the extreme end of this spectrum are patients requiring renal replacement therapy and ECMO support This subgroup of critically ill patients have been found to have high mortality
The concept of attenuating severe hyperinflammatory response is sometimes used in certain disease states using agents such as intravenous corticosteroids plasma exchange and more recently anti-cytokine monoclonal antibodies However these strategies are associated with side effects eg Bleeding and increased risk of infection and are not necessarily appropriate in all critically ill patients with severe inflammation Studies investigating the efficacy of these strategies have failed to show any clinical benefit except in the setting of COVID 19 infection1-4 Early use of cytokine adsorption devices may provide an alternative non- pharmacological pathway with fewer side effects which can be deployed early
The most studied cytokine adsorption device is the CytoSorb column which consists of biocompatible polymer sorbent beads Several studies have demonstrated a reduction in vasopressor requirements IL-6 levels and Sequential Organ Failure Assessment SOFA scores56 However this observation did not translate into outcome benefit There is considerable heterogeneity in how the cytokine adsorption is delivered in these studies and the study designs An international registry analysis did not demonstrate a mortality benefit with CytoSorb either7
The HA380 column consists of styrene divinylbenzene copolymers In a recent study consisting of patients undergoing cardio-pulmonary bypass patients who received the HA 380 column required lower vasopressor doses shorter duration of invasive mechanical ventilation and had a shorter ICU length of stay8 A direct in- vitro comparison of the CytoSorb device and the HA 380 device shows that the latter is less efficient at removing cytokines compared to the CytoSorb device but both devices were efficient at removing pro-inflammatory cytokines9 The role of cytokines in critical illness is a double-edged sword10 and this may well be where CytoSorb may have a disadvantage - providing higher cytokine clearance for a longer period
We hypothesise that the HA380 column use in critically ill patients with inflammation receiving renal replacement therapy or ECMO is associated with an improvement in mortality It is recommended to be used early within 72 hours of commencement of extracorporeal support HA380 hemoperfusion cartridge mainly adsorbs molecules from 10 to 60 kDa Because of the accurate 3D macroporous structure and over 54000 m2 adsorption surface area of the resinHA380 haemoperfusion therapy can provide a new regimen in controlling inflammatory cytokines storm Studies have demonstrated the ability of the HA380 column to reduce the concentration of pro-inflammatory cytokines IL-1 TNF-alpha 1112
The aim of this feasibility pilot is to assess the feasibility of the early use of the HA380 cytokine adsorption column in a study and its effect on the time-to-liberation from extracorporeal membrane oxygenation ECMO support vasoactive drug requirement and duration of vasoactive therapy and mortality or clinical surrogates for all-cause mortality
The concept of attenuating severe hyperinflammatory response is sometimes used in certain disease states using agents such as intravenous corticosteroids plasma exchange and more recently anti-cytokine monoclonal antibodies However these strategies are associated with side effects eg Bleeding and increased risk of infection and are not necessarily appropriate in all critically ill patients with severe inflammation Studies investigating the efficacy of these strategies have failed to show any clinical benefit except in the setting of COVID 19 infection1-4 Early use of cytokine adsorption devices may provide an alternative non- pharmacological pathway with fewer side effects which can be deployed early
The most studied cytokine adsorption device is the CytoSorb column which consists of biocompatible polymer sorbent beads Several studies have demonstrated a reduction in vasopressor requirements IL-6 levels and Sequential Organ Failure Assessment SOFA scores56 However this observation did not translate into outcome benefit There is considerable heterogeneity in how the cytokine adsorption is delivered in these studies and the study designs An international registry analysis did not demonstrate a mortality benefit with CytoSorb either7
The HA380 column consists of styrene divinylbenzene copolymers In a recent study consisting of patients undergoing cardio-pulmonary bypass patients who received the HA 380 column required lower vasopressor doses shorter duration of invasive mechanical ventilation and had a shorter ICU length of stay8 A direct in- vitro comparison of the CytoSorb device and the HA 380 device shows that the latter is less efficient at removing cytokines compared to the CytoSorb device but both devices were efficient at removing pro-inflammatory cytokines9 The role of cytokines in critical illness is a double-edged sword10 and this may well be where CytoSorb may have a disadvantage - providing higher cytokine clearance for a longer period
We hypothesise that the HA380 column use in critically ill patients with inflammation receiving renal replacement therapy or ECMO is associated with an improvement in mortality It is recommended to be used early within 72 hours of commencement of extracorporeal support HA380 hemoperfusion cartridge mainly adsorbs molecules from 10 to 60 kDa Because of the accurate 3D macroporous structure and over 54000 m2 adsorption surface area of the resinHA380 haemoperfusion therapy can provide a new regimen in controlling inflammatory cytokines storm Studies have demonstrated the ability of the HA380 column to reduce the concentration of pro-inflammatory cytokines IL-1 TNF-alpha 1112
The aim of this feasibility pilot is to assess the feasibility of the early use of the HA380 cytokine adsorption column in a study and its effect on the time-to-liberation from extracorporeal membrane oxygenation ECMO support vasoactive drug requirement and duration of vasoactive therapy and mortality or clinical surrogates for all-cause mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 340810 | OTHER | IRAS | None |