Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support for Acute Critical Illness; a Prospective, Randomised, Interventional, Feasibility, Pilot Study (HACEC)
University Hospitals, Leicester
40 participants
Sep 2, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- Consent obtained
- Male or Female, aged 18 years - 65 years.
- Admitted with a diagnosis of sepsis (according to sepsis-3 definition), trauma, ARDS of infectious or non-infectious aetiology, trauma or after major surgery
- Need for extracorporeal support and specifically renal replacement therapy (RRT) and/or ECMO.
- Vasopressor or inotropic therapy requirement at the time of RRT or ECMO support
- Within 72 hours of requiring extracorporeal support
- At least one of:
- CRP \> 100 mg/L (in the absence of immunosuppressive therapy/immunomodulation)
- Lactate \>2 mmol/L
Exclusion Criteria9
- The participant may not enter the trial if ANY of the following apply:
- Unable to obtain consent.
- Expected to die in the next 24 hours.
- Pre-existing chronic kidney disease - requiring dialysis /eGFR \< 30ml/min/1.73m2
- Pre-existing severe respiratory failure - e.g., requiring home oxygen/ home nebulisers/ poor exercise tolerance
- Chronic heart failure - NYHA class III and above
- Pregnancy
- Requirement for immediate immune modulation e.g., plasma exchange, high dose steroids , IV immunoglobulins (does not include vasoplegic dose of steroids or immune modulation for COVID 19)
- Participants who have participated in another research trial involving an investigational product in the past 12 weeks.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
HA380 hemoperfusion cartridge is filled with neutral macroporous resin, mainly adsorbing molecules from 10 to 60 kDa. Because of the accurate 3D macroporous structure and over 54000 m2 adsorption surface area of the resin. The cartridge is attached to the extracorporeal circuit in series with the oxygenator/ filter of the extracorporeal circuit.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06179771