Status:
RECRUITING
Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
Lead Sponsor:
University Hospitals, Leicester
Collaborating Sponsors:
Jafron Biomedical Company Limited
Conditions:
Acute Kidney Injury
ARDS
Eligibility:
All Genders
18-65 years
Phase:
NA
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 E...
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 ma...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06179771
Start Date
November 12 2024
End Date
May 1 2027
Last Update
March 30 2025
Active Locations (1)
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1
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, United Kingdom, LE3 9QP