Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 1
- 主要终点
- Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
研究概览
简要总结
Observational studies among critically ill patients have shown strong associations between vitamin D deficiency and adverse outcomes, including increased length of stay, infection, and mortality. It is unknown whether vitamin D deficiency contributes directly to adverse outcomes or whether it is simply a biomarker of severity of illness or overall health status. However, vitamin D plays a key role in host defense, largely by stimulating production of the anti-microbial peptide cathelicidin (LL-37). We will test the hypothesis that administration of activated vitamin D (calcitriol) will increase serum levels of cathelicidin.
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
- 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
- •Severe sepsis or septic shock
- •Central venous catheter (for blood drawing)
排除标准
- •Serum calcium ≥ 10.0 mg/dl or phosphate ≥ 6.0 mg/dl, assessed within previous 48 hours
- •Current or recent therapy (within previous 7 days) with nutritional vitamin D at doses >1,000 I.U. per day or activated vitamin D at any dose
- •History of solid organ or bone marrow transplant, primary parathyroid disease, metabolic bone disease, or sarcoidosis
- •Expected to die or leave the ICU within 48 hours
- •History of hypersensitivity or any allergic reaction to calcitriol
- •End stage renal disease
- •Acute Kidney Injury receiving intermittent renal replacement therapy
- •Enrolled in a competing study
- •Pregnancy
研究组 & 干预措施
Placebo
Normal saline 2cc IV x 1
干预措施: Placebo (Drug)
Calcitriol
Calcitriol 2mcg IV x 1
干预措施: Calcitriol (Drug)
结局指标
主要结局
Plasma Cathelicidin (hCAP18) Protein Levels at 48 Hours
时间窗: 48 hours
次要结局
- Plasma Interleukin-6 (IL-6) Levels at 48 Hours(48 hours)
- Urinary Neutrophil Gelatinase-associated Lipocalin (NGAL) / Creatinine Ratio at 48 Hours(48 hours)
研究者
David Leaf
Assistant Professor of Medicine, Harvard Medical School
Brigham and Women's Hospital