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New treatment option for Acute Kidney Injury
Official title Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.
ClinicalTrials.gov ID: NCT06179771
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Leicester, Leicestershire, United Kingdom
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Leicester, Leicestershire, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.