ChiCTR2500102159 版本V1.0 版本创建时间2025/05/09 11:49:52 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2500102159 

最近更新日期：

Date of Last Refreshed on：

 2025-05-09 11:49:34 

注册时间：

Date of Registration：

 2025-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of taurine in reducing acute kidney injury

Public title：

Effect of taurine in reducing acute kidney injury

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Pik Yi HOU 

研究负责人：

Anna LEE 

Applicant：

Pik Yi HOU 

Study leader：

Anna LEE 

申请注册联系人电话：

Applicant telephone：

 +852 3505 1907

研究负责人电话：

Study leader's
telephone：

+852 3505 2735

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 gracehou@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 annalee@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

研究负责人通讯地址：

Office 21, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Applicant address：

4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong

Study leader's address：

Office 21, 4/F Main Clinical Block and Trauma Centre, Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

Applicant's institution：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

研究负责人所在单位：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

Affiliation of the Leader：

Department of Anesthesia and Intensive Care, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025.083-T

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-26 00:00:00

伦理委员会联系人：

Envy LEE

Contact Name of the ethic committee：

Envy LEE

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Prince of Wales Hospital

Primary sponsor：

Prince of Wales Hospital

研究实施负责（组长）单位地址：

Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Primary sponsor's address：

Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

Prince of Wales Hospital

具体地址：

Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

Institution
hospital：

Prince of Wales Hospital

Address：

Prince of Wales Hospital, Shatin, NT, Hong Kong SAR, China

经费或物资来源：

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

Source(s) of funding：

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

研究疾病：

acute kidney injury  

Target disease：

acute kidney injury

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

The study taurine and placebo capsules are indistinguishable in appearance, produced by Optima Ovest, a company from Western Australia. Indistinguishable placebo (1g capsule x 4 in one sitting) [Colorcon called StarCap - a mixture of Pregelatinized Maize Starch and Maize Starch]. 

Description for medicine or protocol of treatment in detail：

The study taurine and placebo capsules are indistinguishable in appearance, produced by Optima Ovest, a company from Western Australia. Indistinguishable placebo (1g capsule x 4 in one sitting) [Colorcon called StarCap - a mixture of Pregelatinized Maize Starch and Maize Starch]. 

纳入标准：

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。

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2028-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-01 00:00:00 至 To 2027-06-30 00:00:00

干预措施：

Interventions：

组别：

intervention group

样本量：

 45

Group：

intervention group

Sample size：

干预措施：

Participants in this group will receive 4g of taurine (1g/capsule x 4 in one sitting) orally the day before surgery, and 4g daily orally for two days post-surgery (or via nasogastric tube if needed post-surgery). Taurine will be continued and blood tests will also be taken on day 2 on the ward if the participant is discharged before the morning of day 2 in ICU (rare occasion)

干预措施代码：

Intervention：

Participants in this group will receive 4g of taurine (1g/capsule x 4 in one sitting) orally the day before surgery, and 4g daily orally for two days post-surgery (or via nasogastric tube if needed post-surgery). Taurine will be continued and blood tests will also be taken on day 2 on the ward if the participant is discharged before the morning of day 2 in ICU (rare occasion)

Intervention code：

组别：

control group

样本量：

 45

Group：

control group

Sample size：

干预措施：

Participants in this group will receive an indistinguishable placebo (1g/capsule x 4 in one sitting) [Colorcon called StarCap - a mixture of pregelatinized maize starch and maize starch] orally the day before surgery, and 4g daily orally for two days post-surgery (or via nasogastric tube if needed pos-surgery)

干预措施代码：

Intervention：

Participants in this group will receive an indistinguishable placebo (1g/capsule x 4 in one sitting) [Colorcon called StarCap - a mixture of pregelatinized maize starch and maize starch] orally the day before surgery, and 4g daily orally for two days post-surgery (or via nasogastric tube if needed pos-surgery)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Prince of Wales Hospital 

单位级别：

 Tertiary  

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

urinary concentrations of tissue inhibitor of metalloproteinase (TIMP-2)

指标类型：

主要指标

Outcome：

urinary concentrations of tissue inhibitor of metalloproteinase (TIMP-2)

Type：

Primary indicator

测量时间点：

baseline (before surgery), day 1 and day 2 after surgery

测量方法：

NephroCheck?

Measure time point of outcome：

baseline (before surgery), day 1 and day 2 after surgery

Measure method：

NephroCheck?

指标中文名：

insulin-like growth factor-binding protein (IGFBP7)

指标类型：

主要指标

Outcome：

insulin-like growth factor-binding protein (IGFBP7)

Type：

Primary indicator

测量时间点：

baseline (before surgery), day 1 and day 2 after surgery

测量方法：

NephroCheck?

Measure time point of outcome：

baseline (before surgery), day 1 and day 2 after surgery

Measure method：

NephroCheck?

指标中文名：

KDIGO

指标类型：

主要指标

Outcome：

KDIGO

Type：

Primary indicator

测量时间点：

baseline (before surgery), day 1 and day 2 after surgery

测量方法：

combined the results of TIMP-2 and IGFBP7

Measure time point of outcome：

baseline (before surgery), day 1 and day 2 after surgery

Measure method：

combined the results of TIMP-2 and IGFBP7

指标中文名：

plasma HO-1

指标类型：

次要指标

Outcome：

plasma HO-1

Type：

Secondary indicator

测量时间点：

day 1 and day 2 after surgery

测量方法：

blood test

Measure time point of outcome：

day 1 and day 2 after surgery

Measure method：

blood test

指标中文名：

urinary HO-1

指标类型：

次要指标

Outcome：

urinary HO-1

Type：

Secondary indicator

测量时间点：

day 1 and day 2 after surgery

测量方法：

urinary test

Measure time point of outcome：

day 1 and day 2 after surgery

Measure method：

urinary test

指标中文名：

urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL)

指标类型：

次要指标

Outcome：

urinary concentrations of neutrophil gelatinase-associated lipocalin (NGAL)

Type：

Secondary indicator

测量时间点：

day 1 and day 2 after surgery

测量方法：

urinary test

Measure time point of outcome：

day 1 and day 2 after surgery

Measure method：

urinary test

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

blood

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

标本中文名：

urine

组织：

Sample Name：

urine

Tissue：

人体标本去向

 使用后保存  

说明

Fate of sample：

Preservation after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age NA 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

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.

Blinding：

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.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

not for sharing unless with reasonable request

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

not for sharing unless with reasonable request

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

All data will be collected by trained staff including demographic data, plasma and urine samples. Plasma and urine samples will be frozen and stored at -80C for subsequent analysis using commercially available ELISA and NephroCheck kits. These samples will be stored up to 3 years and there are no further plans for future use. Demographic data will be captured from existing ICU Clinical Information Systems. All data will be recorded on a prespecified eCRF using REDCap, for which is a secure web-based case report located on the CUHK server.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All data will be collected by trained staff including demographic data, plasma and urine samples. Plasma and urine samples will be frozen and stored at -80C for subsequent analysis using commercially available ELISA and NephroCheck kits. These samples will be stored up to 3 years and there are no further plans for future use. Demographic data will be captured from existing ICU Clinical Information Systems. All data will be recorded on a prespecified eCRF using REDCap, for which is a secure web-based case report located on the CUHK server.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-05-09 11:49:34