NCT06179771 Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
| NCT ID | NCT06179771 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospitals, Leicester |
| Condition | Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-09-02 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria * 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 Criteria * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06179771 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06179771 currently recruiting?
Yes, NCT06179771 is actively recruiting participants. Contact the research team at hakeem.yusuff1@nhs.net for enrollment information.
Where is the NCT06179771 trial being conducted?
This trial is being conducted at Leicester, United Kingdom.
Who is sponsoring the NCT06179771 clinical trial?
NCT06179771 is sponsored by University Hospitals, Leicester. The trial plans to enroll 40 participants.
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