Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury (ACTIVATE-AKI)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Death Within 7 Days
研究概览
简要总结
The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of acute kidney injury (AKI) in critically ill patients.
详细描述
Decreased circulating levels of active vitamin D metabolites, including 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D (1,25D), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (AKI). Further, administration of 25D and 1,25D attenuates AKI in animal models. The purpose of this study is to assess if administration of 25D and 1,25D decreases the incidence and severity of AKI in critically ill patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 the ICU within 48h prior to enrollment
- •Likely to remain in the ICU (alive) for ≥72h
- •Naso/orogastric tube or ability to swallow
- •High risk of severe AKI
排除标准
- •Serum total calcium > 9.0 mg/dl or phosphate > 6.0 mg/dL within previous 48h
- •Currently receiving oral calcium supplementation
- •Ingestion of vitamin D3 >1,000 IU/day or any 25-hydroxyvitamin D or 1,25-dihydroxyvitamin D during the previous 7 days
- •AKI stage 2 or 3 (based on KDIGO serum creatinine and/or urine output criteria)
- •History of transplantation or receiving chronic (>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day)
- •Neutropenia in the previous 48h
- •Active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months
- •Receiving cytochrome P450 inhibitors
- •Chronic Kidney Disease stage V or End Stage Renal Disease
- •Hemoglobin < 7 g/dL
- •GI malabsorption
- •Pregnancy or breast feeding
研究组 & 干预措施
Calcifediol
Calcifediol 400mcg orally x 1, followed by 200mcg orally daily x 4
干预措施: Calcifediol (Drug)
Calcitriol
Calcitriol 4mcg orally daily x 5 days
干预措施: Calcitriol (Drug)
Placebo
Equal volume of medium chain triglyceride (MCT) oil orally daily x 5 days
干预措施: Placebos (Drug)
结局指标
主要结局
Death Within 7 Days
时间窗: 7 days
All-cause mortality within 7 days following randomization
Number of Participants Who Received Renal Replacement Therapy Within 7 Days
时间窗: 7 days
Number of participants who received renal replacement therapy within 7 days following randomization
Relative Average Change in Serum Creatinine From Day 0 to Days 1-7
时间窗: 7 days
Average percentage change in serum creatinine assessed on days 1-7 as compared to day 0
次要结局
- Number of Participants With New or Worsening Stage of AKI, Defined by KDIGO Guidelines(7 days)
- 28-day Mortality(28 days)
- ICU- and Hospital-free Days(28 days)
- Peak Serum Creatinine (mg/dl)(7 days)
研究者
David Leaf
Assistant Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital