A Multi-Center, Randomized, Controlled, Pivotal Study to Assess the Safety and Efficacy of a Selective Cytopheretic Device in Patients With Acute Kidney Injury Requiring Continuous Kidney Replacement Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 339
- 试验地点
- 65
- 主要终点
- Composite endpoint of mortality or dialysis dependency at 90 days
研究概览
简要总结
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. This study will enroll approximately 339 subjects across 30 US sites. Participants will be patients in an intensive care unit (ICU) setting with a diagnosis of AKI requiring CKRT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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-
- •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 reasonable suspicion that the subject has non-ATN AKI based on this, they will be excluded from the trial.
- •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/mm
- •Patient is a prisoner or member of a vulnerable population.
- •Patient is pregnant or breast feeding.
- •Concurrent enrollment in another interventional clinical trial for an investigational drug or device.
- •Need for plasmapheresis.
研究组 & 干预措施
SCD + CKRT Arm
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.
干预措施: Selective Cytopheretic Device (Device)
CKRT Alone Arm (standard of care)
This arm will receive standard of care CKRT therapy for their condition as appropriate.
干预措施: Standard of Care (Other)
结局指标
主要结局
Composite endpoint of mortality or dialysis dependency at 90 days
时间窗: 90 days
The composite of death or requiring kidney replacement therapy at 90 days post randomization
次要结局
- Dialysis dependence(1 year)
- MAKE90(90 days)
- Mortality at 28 days(28 days)
- ICU free days in the first 28 days(28 days)