ChiCTR2400091167 版本V1.0 版本创建时间2024/10/22 15:58:13 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：

ChiCTR2400091167 

最近更新日期：

Date of Last Refreshed on：

2024-10-22 15:57:54 

注册时间：

Date of Registration：

2024-10-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

肾移植术后肾血管阻力指数与肾移植物功能恢复延迟的相关性

Public title：

Correlation between renal vascular resistance index and delayed renal graft function after renal transplantation

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肾移植患者术后肾血管阻力指数与将移植物功能恢复延迟 DGF 的相关性

Scientific title：

Correlation between color Doppler-based renal blood flow and delayed graft function(DGF) in renal transplant patients

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：

江莹 

研究负责人：

江莹 

Applicant：

Ying Jiang  

Study leader：

Ying Jiang  

申请注册联系人电话：

Applicant telephone：

+86 158 8010 0211

研究负责人电话：

Study leader's telephone：

+86 158 8010 0211

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：

jy-meave@163.com

研究负责人电子邮件：

Study leader's E-mail：

jy-meave@163.com

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：

中国福建省福州市东街134号

研究负责人通讯地址：

中国福建省福州市东街134号

Applicant address：

No. 134 East Street, Fuzhou City, Fujian Province, China

Study leader's address：

No. 134 East Street, Fuzhou City, Fujian Province, 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：

福州大学附属省立医院

Applicant's institution：

Fuzhou University Affiliated Provincial Hospital

研究负责人所在单位：

福州大学附属省立医院

Affiliation of the Leader：

Fuzhou University Affiliated Provincial Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

伦审科研第(K2024-08-001)号

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：

福建省立医院伦理委员会

Name of the ethic committee：

Ethics Committee of Fujian Provincial Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-08-06 00:00:00

伦理委员会联系人：

练发杨

Contact Name of the ethic committee：

Fayang Lian

伦理委员会联系地址：

福建省福州市鼓楼区秘书巷12号省立公寓（二层科研科）

Contact Address of the ethic committee：

No. 12, Secretary Lane, Gulou District, Fuzhou City, Fujian Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 136 4508 9026

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：

福州大学附属省立医院

Primary sponsor：

Fuzhou University Affiliated Provincial Hospital

研究实施负责（组长）单位地址：

中国福建省福州市东街134号

Primary sponsor's address：

No. 134 East Street, Fuzhou City, Fujian Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建

市(区县)：

Country：

China

Province：

Fujian

City：

单位(医院)：

福州大学附属省立医院

具体地址：

中国福建省福州市东街134号

Institution
hospital：

Fuzhou University Affiliated Provincial Hospital

Address：

No. 134 East Street, Fuzhou City, Fujian Province, China

经费或物资来源：

其他（重症医学（国家重点专科））

Source(s) of funding：

Intensive Care Medicine(National Key Clinical Specialty Construction Project)

Target disease：

delayed graft function,DGF

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

病例对照研究 

Study design：

Case-Control study 

研究目的：

进一步探讨基于彩色多普勒的肾血流在DGF中的应用价值，多维探讨比较移植肾的各级肾血管的不同血流指标与DGF的相关性，发现最佳评价血管、评价指标，以及合适的临床监测时间窗，将有助于移植专业团队更好的交流，有助于优化DGF的诊断及预后判断。建立基于彩色多普勒的肾血流的DGF预测模型，在临床上以早期识别DGF，挖掘潜在的治疗靶点、寻找有效的临床治疗手段，给予恰当干预，挽救DGF，从而改善远期移植物存活率和患者生存率。  

Objectives of Study：

Further exploring the application value of color Doppler-based renal blood flow in DGF, multidimensional exploration and comparison of the correlation between different blood flow indexes of all levels of renal vessels in transplanted kidneys and DGF, and discovering the optimal evaluation vessels and indexes, as well as the appropriate time window for clinical monitoring, will help the transplantation team of specialists to have a better communication, and will help to optimize the diagnosis and prognosis judgment of DGF. The establishment of a DGF prediction model based on color Doppler renal blood flow is clinically useful for early identification of DGF, mining potential therapeutic targets, searching for effective clinical treatments, and giving appropriate interventions to save DGF, thus improving long-term graft survival and patient survival.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

因肾移植术后转入ICU的患者

Inclusion criteria

Patients transferred to the ICU for kidney transplantation

排除标准：

1: 年龄<18岁； 2: 术后出现移植肾输尿管梗阻 3: 诊断DGF时间早于第一次彩超时间

Exclusion criteria：

1: Age <18 years 2: postoperative ureteral obstruction of the transplanted kidney 3: Diagnosis of DGF earlier than the time of the first ultrasound

研究实施时间：

Study execute time：

从 From 2024-08-27 00:00:00至 To 2024-09-10 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-08-27 00:00:00 至 To 2024-08-31 00:00:00  

干预措施：

Interventions：

组别：

DGF组

样本量：

35

Group：

DGF Group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

组别：

非DGF组

样本量：

89

Group：

No DGF

Sample size：

干预措施：

无

干预措施代码：

Intervention：

NA

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

  

Country：

China 

Province：

Fujian 

City：

 

单位(医院)：

福州大学附属省立医院 

单位级别：

三甲 

Institution
hospital：

Fuzhou University Affiliated Provincial Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肾动脉主干的收缩期血流峰值速率

指标类型：

主要指标

Outcome：

Vs of Renal Artery Main Trunk

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在肾动脉主干取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal artery trunk with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were measured

指标中文名：

肾动脉主干的舒张期最低血流速度

指标类型：

主要指标

Outcome：

Vd of Renal Artery Main Trunk

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在肾动脉主干取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal artery trunk with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were measured

指标中文名：

段动脉的收缩期血流峰值速率

指标类型：

主要指标

Outcome：

Vs of Renal Segmental Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在段动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal segmental arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were mea

指标中文名：

段动脉的收缩期血流峰值速率

指标类型：

主要指标

Outcome：

Vd of Renal Segmental Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在段动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal segmental arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were mea

指标中文名：

叶间动脉的收缩期血流峰值速率

指标类型：

主要指标

Outcome：

Vs of Interlobar Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在叶间动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal interlobar arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were me

指标中文名：

叶间动脉的舒张期最低血流速度

指标类型：

主要指标

Outcome：

Vd of Interlobar Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在叶间动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal interlobar arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were me

指标中文名：

小叶间动脉的收缩期血流峰值速率

指标类型：

主要指标

Outcome：

Vs of Interlobular Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在小叶间动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal interlobular arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were

指标中文名：

小叶间动脉的舒张期最低血流速度

指标类型：

主要指标

Outcome：

Vd of Interlobular Arteries

Type：

Primary indicator

测量时间点：

肾移植术后24h内

测量方法：

取仰卧位，于移植侧髂窝探及移植肾声影。显示肾脏彩色血流图像，用脉冲多普勒在小叶间动脉取样，声束与血流方向夹角小于60度，显示脉冲波多普勒频谱，用游标测量收缩期最大血流速度Vs、舒张期最低血流速度Vd及平均速度Vm，取连续3个动脉波形的平均值。

Measure time point of outcome：

Within 24 hours after renal transplantation

Measure method：

In the supine position, the acoustic shadow of the transplanted kidney was explored in the iliac fossa on the transplanted side. Color blood flow images of the kidney were displayed, and pulsed Doppler was used to sample the renal interlobular arteries with the angle between the sound beam and the direction of blood flow less than 60 degrees, showing the pulsed-wave Doppler spectrum, and the maximal systolic flow velocity Vs, the minimal diastolic flow velocity Vd, and the mean velocity Vm were

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

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

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

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）：

2025.01.01，http://www.medresman.org.cn/login.aspx

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

2025.01.01, http://www.medresman.org.cn/login.aspx

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：

电子采集和管理系统

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

an electronic data capture

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-10-22 15:57:54