Strategies to Stop Acute Kidney Injury (AKI)-Acute Kidney Disease (AKD) -Chronic Kidney Disease (CKD) Continuum - Policy The Intensified AKD Care to Reduce CKD
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 690
- 主要终点
- Proportion of Major adverse kidney event
研究概览
简要总结
Strategies to stop AKI-AKD-CKD continuum - Policy is one of the collaborative projects, Strategies to stop AKI-AKD-CKD continuum, Epidemiology, Immunology, Repair, Artificial intelligence, and Policy (EIRAP). It is aimed to study effective interventional strategies that lower the incidence of CKD among patients with AKD. The intensified AKD care to reduce CKD (ISACC trial) is a prospective, open-labeled, randomized controlled trial is designed to evaluate the efficacy of multidisciplinary team care (MDT) model and acute kidney disease (AKD) clinic visits
详细描述
Acute kidney disease (AKD), defined as the ongoing renal function impairment between 7 days and 90 days following AKI, has been proposed as a window of intervention to prevent the occurrence of CKD. However, the effective therapeutic strategies of AKD care remain to be developed. We intend to conduct a prospective, randomized, open-label, behavioral interventional trial to validate the efficacy of multidisciplinary team (MDT) care model which aims to improve AKD care and to reduce de novo CKD incidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 20 yrs
- •Severe AKD: Stage 2, Stage 3 and Dialysis-requiring AKD (AKD-D)
排除标准
- •Pregnancy
研究组 & 干预措施
Intensified care
Experimental: Multidisciplinary team (MDT) care + Acute kidney disease (AKD) clinic Participants randomized to this arm will receive multidisciplinary team (MDT) care by a specialized medical team which is composed of nephrologist, pharmacist and dietitian. Besides intensified care, participants of this arm receive evaluation of biochemical and physiological renal function more frequently. In order to provide seamless care of this group, post-discharge acute kidney disease (AKD) clinic will also be arranged for them. Clinic visits consist of evaluation of renal function, reconciliation of medication and steering necessity of renal replacement therapy.
干预措施: Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic (Behavioral)
Usual care
No intervention: Usual care Participants randomized to this arm will receive usual care according to the medical decisions of principal care physician. Nephrologist consultation and nephrology outpatient clinic follow-up will be allowed. However, this group of patient will not have access to MDT care and AKD clinic.
结局指标
主要结局
Proportion of Major adverse kidney event
时间窗: 90days
Proportion of MAKE * Renal progression to CKD * Chronic dialysis (any 1 outpatient dialysis after discharge) * Death
次要结局
- Mortality(30days, 60days, 90days, 180days, 360 days, 3years)
- Proportion of MACE(30days, 60days, 90days, 180days, 360 days, 3years)
- Time to first ER visit(90days, 180days, 1year (360days))
- Renal progression(90days, 180days, 360 days, 3years)
- Time to first recurrence of AKI(90days, 180days, 1year (360days))
- Time to MAKE(90days, 180days, 1year (360days))
- Time to death(90days, 180days, 1year (360days))
- Time to chronic dialysis(90days, 180days, 1year (360days))
- Time to renal progression to CKD(90days, 180days, 1year (360days))
- Time to first rehospitalization(90days, 180days, 1year (360days))
- Chronic dialysis(90days, 180days, 360 days, 3years)
研究者
Shuang-Ho Hospital, the EIRAP project
Stop AKI-AKD-CKD continuum in Taiwan: from precision medicine to policy decision (EIRAP study)
Taipei Medical University Shuang Ho Hospital