Recovery After Dialysis-Requiring Acute Kidney Injury Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Protocol adherence [feasibility measure]
研究概览
简要总结
The Recovery After Dialysis-Requiring Acute Kidney Injury (RAD-AKI) Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI), comparing conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy" in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present. The overall hypothesis is that the current practice of thrice-weekly acute intermittent hemodialysis for AKI-D masks evidence of renal recovery and may actually delay or preclude recovery. The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
详细描述
The recent landmark Artificial Kidney Initiation in Kidney Injury (AKIKI) trial showed that a delayed strategy for RRT initiation among patients with incident stage 3 AKI - in which RRT was delayed unless specific metabolic or clinical indications for RRT were present - was safe and averted the need for RRT in nearly half of the critically ill participants, in comparison to an early RRT initiation strategy. The hypothesis for this study is: for prevalent patients with established AKI-D, a conservative dialysis strategy - in which hemodialysis is not continued unless specific metabolic or clinical indications for RRT are present - will shorten time to RRT-independence and improve the likelihood of renal recovery.
The RAD-AKI Pilot Study is a 2-arm randomized clinical trial of hospitalized patients with dialysis-requiring acute kidney injury (RAD-AKI) that will compare conventional thrice-weekly intermittent hemodialysis dialysis (control) to a "conservative dialysis strategy." The primary objective of this pilot study is to assess the safety and feasibility of the proposed intervention and study design.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult inpatients with AKI-D due to acute tubular necrosis who have already initiated renal replacement therapy
- •If initiated on CRRT, patients will be eligible only if they have already tolerated 1 intermittent hemodialysis (IHD) session at the research site.
- •If transferred from an outside hospital, eligible patients must have tolerated 1 IHD session at the research site prior to enrollment.
- •Not requiring vasopressor support
- •Not intubated and not having a supplemental oxygen requirement of >5 L/min via nasal cannula
- •Treating MDs (nephrology and primary team attendings) and patient (or legally authorized representative) consent to enrollment
排除标准
- •Diagnosis of end-stage renal disease (ESRD) or chronic dialysis prior to hospitalization
- •Baseline estimated glomerular filtration rate (eGFR) <15 mL/min/1.73m2
- •Liver transplant unit patients
- •Patients who underwent kidney transplantation during index hospitalization
- •Cause of AKI-D is complete nephrectomy
- •Current pregnancy
结局指标
主要结局
Protocol adherence [feasibility measure]
时间窗: Through completion of active study participation (anticipated <2 weeks for each participant)
Number of times a participant in the "conservative dialysis" arm receives dialysis despite not meeting one of the pre-specified indications for dialysis, number of times a participant in the "TIW dialysis" arm is dialyzed off-schedule
Number of participants with adverse events in each arm [safety measure]
时间窗: Through completion of active study participation (anticipated <2 weeks for each participant)
Both serious and non-serious adverse events will be monitored, including arrhythmias due to metabolic disturbances, death, emergent dialysis needs, and transfer to ICU or intubation after enrollment
次要结局
- Screen-to-enroll ratio [feasibility measure](Through study completion (anticipated 2 years total))
- Patient-reported symptoms(Through completion of active study participation (anticipated <2 weeks for each participant))
- Hospital length of stay(Through completion of active study participation (anticipated <2 weeks for each participant))
- Recovery status at 30, 60, and 90 days after dialysis initiation(From enrollment to 90 days after dialysis initiation for each patient)