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New treatment option for Acute Kidney Injury
Official title Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
ClinicalTrials.gov ID: NCT05758077
What this study is testing
- What it's testing
- This randomized, controlled, pivotal study is intended to determine whether up to ten sequential 24-hour treatments with the Selective Cytopheretic Device (SCD) will improve survival in patients with Acute Kidney Injury (AKI) requiring continuous kidney replacement therapy (CKRT) when compared to CKRT alone (standard of care). This study is further intended to determine whether SCD therapy will reduce the duration of maintenance dialysis secondary to AKI.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Admitted to an ICU requiring CKRT:
- Must have AKI stage 2 or greater at the time of CKRT initiation.
- Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
- At least 18 years of age but not older than 80 at the time of enrollment.
- One additional life-threatening organ dysfunction present.
You likely can't join if
- Not expected to survive next 24 hours.
- Anticipated transition to comfort measures or hospice in next 4 days.
- Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
- Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
- ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
- Active COVID-19 infection with a primary admission diagnosis of COVID-19.
See the full eligibility criteria
- Admitted to an ICU requiring CKRT:
- Must have AKI stage 2 or greater at the time of CKRT initiation.
- Must have been on CKRT for at least 12 hours but no greater than 48 hours at the time of enrollment.
- At least 18 years of age but not older than 80 at the time of enrollment.
- One additional life-threatening organ dysfunction present.
- Acceptable vascular access for CKRT to include adequate lumen size and length of catheters.
- Initial (non-binding) commitment to maintaining current level of care for at least 96 hours.
- C-Reactive Protein \>3.5 mg/dl.
- Not expected to survive next 24 hours.
- Anticipated transition to comfort measures or hospice in next 4 days.
- Terminal condition whereby the patient is not expected to survive 28 days or any condition in which therapy is regarded as futile by the PI.
- Advanced malignancy which is actively being treated or may be treated with palliative chemotherapy or radiation.
- ICU hospitalization \> 14 days during this hospital admission (to include days spent at ICU of an outside hospital) at the time of screening.
- Active COVID-19 infection with a primary admission diagnosis of COVID-19.
- Chronic use of ventricular assist devices.
- ESRD requiring chronic kidney replacement therapy.
- History of CKD (greater than Stage 3).
- AKI stage 0 or stage 1 at the time of CKRT initiation.
- Non-ATN AKI diagnosis. We intend on relying on local nephrology subspecialty expertise to reasonably exclude non-ATN diagnoses based on clinical suspicions combined with prespecified objective criteria. If there is a...
- Acute coronary syndromes, acute stroke, or acute major vascular compromise requiring medical or surgical interventions within 48 hours of randomization.
- Active hemorrhage requiring blood transfusions at the time of screening.
- Acute on Chronic Liver Failure.
- Suspicion of hepato-renal syndrome.
- Presence of any solid organ transplant at any time prior to admission.
- Severe burns with a modified Baux score \> 100 (%TBSA+Age+17 for Inhalation Injury).
- Bone marrow transplant within the last year.
- Chronic immunosuppression with an average of \>20 mg/day of prednisone or other steroid sparing immunosuppressants for the past 30 days prior to hospital admission.
- Individuals who have a history of primary or secondary immune disorders including, but not limited to, HIV or AIDS.
- Dry weight of \>150kg.
- Platelet count \<15,000/mm3.
- Patient is a prisoner or member of a vulnerable population.
- Patient is pregnant or breast feeding.
- Concurrent enrollment in another treatment clinical trial for an investigational drug or device.
- Need for plasmapheresis.
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Augusta, Georgia, United States
- Gainesville, Georgia, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- Rochester, Minnesota, United States
- Las Vegas, Nevada, United States
- Chapel Hill, North Carolina, United States
+ 15 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Los Angeles, California, United States; Palo Alto, California, United States; San Francisco, California, United States; Aurora, Colorado, United States and 29 more location(s). 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.