Effect of taurine in reducing acute kidney injury
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 试验地点
- 1
- 主要终点
- urinary concentrations of tissue inhibitor of metalloproteinase (TIMP-2)
研究概览
简要总结
Objective 1: We propose a phase II double-blinded randomised controlled trial (RCT) to assess whether perioperative use of oral taurine (4 grams per day for three days) can reduce AKI biomarkers, validated and approved by Food and Drug Administration (FDA), compared to placebo. Objective 2: This trial aims to confirm whether taurine can induce a cellular defense mechanism by upregulating heme oxygenase-1 (HO-1) expression, similar to the effects seen with preconditioning, thereby protecting the kidney compared to placebo. Objective 3: We will delineate the quantitative relationships between serial changes in AKI biomarkers (including the product between urinary tissue inhibitor of metalloproteinases 2 (TIMP-2) and insulin-like growth factor-binding protein 7 (IGFBP7), expressed as [TIMP-2]·[IGFBP7] measured by NephroCheck®) and neutrophil gelatinase-associated lipocalin (NGAL), and plasma and urinary HO-1 concentrations in cardiac surgical patients. Additionally, we will compare the ability of urinary AKI biomarkers and plasma and urinary HO-1 expression to predict stage 1, 2, and 3 AKI as defined by the Kidney Disease: Improving Global Outcomes - KDIGO criteria.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机平行对照
- 盲法
- Double
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •Elective cardiac surgery requiring cardiopulmonary bypass (primary and redo isolated coronary artery bypass grafting, aortic valve repair or replacement, mitral valve repair or replacement, combined coronary artery bypass with valve procedures, repair of septal defects, repair of congenital heart defects, and aortic aneurysm repair surgery).
- •Aged >= 18 years。
排除标准
- •Emergency cardiac surgery when administration of taurine at least 12 hours before initiation of surgery is not possible；
- •Treating clinician believes that trial participation is not in the best interests of the patient；
- •Patients with significant renal impairment (eGFR <30ml/min) will be excluded due to the body’s excretion of excess taurine through the kidneys.
- •Patients undergoing minimally invasive cardiac surgery and endovascular aortic surgery (transcatheter aortic valve implantation) not requiring cardiopulmonary bypass will be excluded to enrich the trial population at high risk of AKI.
研究组 & 干预措施
control group
intervention group
结局指标
主要结局
urinary concentrations of tissue inhibitor of metalloproteinase (TIMP-2)
时间窗: baseline (before surgery), day 1 and day 2 after surgery
insulin-like growth factor-binding protein (IGFBP7)
时间窗: baseline (before surgery), day 1 and day 2 after surgery
KDIGO
时间窗: baseline (before surgery), day 1 and day 2 after surgery
次要结局
- plasma HO-1(day 1 and day 2 after surgery)
- urinary HO-1(day 1 and day 2 after surgery)
- urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL)(day 1 and day 2 after surgery)