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Device
Selective Cytopheretic Device for Acute Kidney Injury (NEUTRALIZE-AKI Trial)
N/A
Recruiting
Research Sponsored by SeaStar Medical
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a device to see if it can improve survival and cut dialysis time for people with acute kidney injury in intensive care units.
Who is the study for?
This trial is for adults aged 18-80 in the ICU with severe Acute Kidney Injury (AKI) needing continuous kidney replacement therapy. They must have another life-threatening organ dysfunction, been on CKRT for 12-48 hours, and not expected to be moved to hospice or comfort care within 96 hours. Exclusions include pregnancy, prisoners, those with certain transplants or cancers under treatment, active COVID-19 as primary diagnosis, heavy bleeding at screening time, and a weight over 150kg.
What is being tested?
The study tests if using the Selective Cytopheretic Device (SCD) alongside standard continuous kidney replacement therapy improves survival rates and reduces dialysis duration in AKI patients compared to standard therapy alone. About 200 participants will receive up to ten sequential treatments of SCD or just standard care across multiple US sites.
What are the potential side effects?
While specific side effects are not listed here, potential risks may include reactions related to device use such as blood clots or infections at catheter sites; immune responses; inflammation; discomfort from prolonged device attachment; and complications from extended dialysis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite endpoint of mortality or dialysis dependency at 90 days
Secondary study objectives
Dialysis dependence
ICU free days in the first 28 days
MAKE90
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: SCD + CKRT ArmExperimental Treatment1 Intervention
In addition to standard of care CKRT therapy for these subjects, these subjects will have up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) in-line with their existing CKRT circuit.
Group II: CKRT Alone Arm (standard of care)Experimental Treatment1 Intervention
This arm will receive standard of care CKRT therapy for their condition as appropriate.
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Who is running the clinical trial?
SeaStar MedicalLead Sponsor
5 Previous Clinical Trials
491 Total Patients Enrolled
ICON plcIndustry Sponsor
85 Previous Clinical Trials
28,276 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently hospitalized with COVID-19 as my main diagnosis.I have had an organ transplant.I haven't had a recent heart attack, stroke, or major blood vessel problem needing immediate treatment.My kidney function is normal or slightly reduced.I have been on continuous kidney replacement therapy for 12 to 48 hours.I have been in the ICU for more than 14 days during this hospital stay.I am in the ICU and need continuous kidney replacement therapy.I am on long-term dialysis for end-stage renal disease.I have a history of moderate to severe kidney disease.My advanced cancer is being treated, or may be treated, with palliative care.My veins are suitable for continuous kidney replacement therapy.I am on long-term medication to suppress my immune system.I am between 18 and 80 years old.I have another serious organ problem.I have a history of immune disorders like HIV/AIDS.I am currently receiving blood transfusions for active bleeding.My kidney injury is at least at stage 2 when starting treatment.I had a bone marrow transplant within the last year.I need a treatment to filter my blood during my hospital stay.My liver is failing despite having a long-term liver condition.I might have a condition affecting my liver and kidneys.
Research Study Groups:
This trial has the following groups:- Group 1: SCD + CKRT Arm
- Group 2: CKRT Alone Arm (standard of care)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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