【ChiCTR2500102159】Effect of taurine in reducing acute kidney injury

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基本信息

登记号

ChiCTR2500102159

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-05-09

临床申请受理号

靶点

适应症

acute kidney injury

试验通俗题目

Effect of taurine in reducing acute kidney injury

试验专业题目

Upregulating Heme Oxygenase-1 by Taurine to reduce Acute Kidney Injury in cardiac surgery: a phase II randomised controlled trial (the HOT-AKI trial)

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机平行对照

试验分期

Ⅱ期

随机化

A permuted block randomisation method with variable block sizes will be used to allocate participants to either taurine or placebo in a 1:1 ratio. Computerised randomisation and allocation concealment will be performed by REDCap – Research Electronic Data Capture, a secure, web-based research data management application by the PI who is not involved in the recruitment, data collection or care of the patients.

盲法

Double blind. The study taurine and placebo capsules are indistinguishable in appearance, produced by Optima Ovest, a company from Western Australia. The only person who is aware of the allocation concealment is the PI and this can be disclosed if adverse events are reported and the clinicians will need to know the identity of the study capsules. These capsules will be stored in our research office. Participants will be given the bottles of study capsules as allocated once enrolled.

试验项目经费来源

Funding for this study is being sought from the General Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-10-01

试验终止时间

2028-07-31

是否属于一致性

入选标准

Inclusion criteria • 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

Exclusion criteria • 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.；

研究者信息

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试验机构

Prince of Wales Hospital

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