Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity Hospitals, Leicester
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
HA 380
DeviceHA380 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.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: InterventionalActive comparator 1 intervention
Group B: Standard careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Successful use of HA380 column in critically ill patients.
Number of patients unable to tolerate treatment with HA380 column.
Time frame
through study completion, an average of 24 months2
Ability to recruit the sample size of eligible patients within the study period.
Proportion of the sample size recruited into the study during the study period.
Time frame
through study completion, an average of 24 monthsSecondary outcomes
1
Time spent on vasopressor therapy.
Hours spent requiring vasopressor support.
Time frame
From date admission to ICU, assessed up to 4 weeks2
Time spent in ICU
Days spent in ICU
Time frame
From date of admission to ICU until the date of ICU discharge or date of death, which ever comes first, assessed up to 24 months3
ICU Mortality
Death in ICU
Time frame
From the date of admission to ICU until the date of death from any cause during ICU stay, assessed up to 24 months4
Time spent on extracorporeal support
Days spent on extracorporeal support.
Time frame
From the date of admission to ICU, assessed up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov