今天是:2019-06-26 星期三

枸橼酸抗凝血液透析抗凝目标的探索性研究及其对患者体内炎症因子和血清甲状旁腺激素水平的影响
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注册号:

Registration number:

ChiCTR1900023801 

最近更新日期:

Date of Last Refreshed on:

2019-06-12 

注册时间:

Date of Registration:

2019-06-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

枸橼酸抗凝血液透析抗凝目标的探索性研究及其对患者体内炎症因子和血清甲状旁腺激素水平的影响 

Public title:

Exploratory study for anticoagulant target of region citrate anticoagulant and its effect on inflammatory factors and serum parathyroid hormone levels in hemodialysis patients 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

枸橼酸抗凝血液透析抗凝目标的探索性研究及其对患者体内炎症因子和血清甲状旁腺激素水平的影响  

Scientific title:

Exploratory study for anticoagulant target of region citrate anticoagulant and its effect on inflammatory factors and serum parathyroid hormone levels in hemodialysis 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:

罗来敏 

研究负责人:

罗来敏 

Applicant:

Laimin Luo 

Study leader:

Laimin Luo 

申请注册联系人电话:

Applicant telephone:

+86 13907913561 

研究负责人电话:

Study leader's telephone:

+86 0791-88692515 

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:

llm090626@163.com 

研究负责人电子邮件:

Study leader's E-mail:

llm090626@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:

江西省南昌市东湖区永外正街17号 

研究负责人通讯地址:

江西省南昌市东湖区永外正街17号 

Applicant address:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, China 

Study leader's address:

17 Yongwai Main Street, Donghu District, Nanchang, Jiangxi, 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:

南昌大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Nanchang University  

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:

2019(30) 

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:

南昌大学第一附属医院医学科研伦理委员会 

Name of the ethic committee:

Medical Research Ethics Committee of the First Affiliated Hospital of Nanchang University  

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

乐爱平 

Contact Name of the ethic committee:

Aiping Le 

伦理委员会联系地址:

江西省南昌市东湖区永外正街17号 

Contact Address of the ethic committee:

17 Yongwai Main Street, Donghu District, Jiangxi, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

南昌大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of Nanchang University  

研究实施负责(组长)单位地址:

江西省南昌市东湖区永外正街17号 

Primary sponsor's address:

17 Yongwai Main Street, Donghu District, Jiangxi, 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):

江西省

市(区县):

南昌市

Country:

China

Province:

Jiangxi

City:

Nanchang

单位(医院):

南昌大学第一附属医院

具体地址:

江西省南昌市东湖区永外正街17号

Institution
hospital:

The First Affiliated Hospital of Nanchang University

Address:

17 Yongwai Main Street, Donghu District, Jiangxi, China

经费或物资来源:

江西省卫生计生委科技计划 

Source(s) of funding:

Science and technology plan of jiangxi provincial health and family planning commission 

研究疾病:

终末期肾病 

Target disease:

End-stage kidney disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1) 观察枸橼酸抗凝血液透析治疗中不同抗凝目标值对抗凝有效性的影响。 2) 观察枸橼酸抗凝对患者不血清炎症因子表达的影响。 3) 观察枸橼酸抗凝患者治疗过程中和治疗后体内iPTH水平的变化。 

Objectives of Study:

1) Observe the effect of different anticoagulation target values on anticoagulant efficacy in dialysis treatment of citrate anticoagulant; 2) Observe the effect of citrate anticoagulation on the expression of serum inflammatory factors in patients; 3) Observe changes in iPTH levels during and after treatment of citrate anticoagulant patients. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1. 住院时间2019年12月1日—2020年7月1日。 2. 维持性血透患者,18-70岁,性别不限。 3. 存在出血倾向或活动性出血的患者进入枸橼酸抗凝组,同期进行治疗的使用肝素抗凝的患者进入对照组。 4. 依从性良好。 5. 签署知情同意书。 

Inclusion criteria

1. Hospitalization time December 1, 2019 - July 1, 2020; 2. Patients with maintenance hemodialysis, aged 18-70 years old male and female; 3. Patients with bleeding tendency or active bleeding entered the citrate anticoagulant group, and patients who received heparin anticoagulation at the same time entered the control group; 4. Good compliance; 5. Sign the informed consent form. 

排除标准:

1、 严重肝功能损害:TBIL≥60umol/L; 2、 不能纠正的低血压<90/60mmHg(组织灌注不足或循环障碍); 3、 低氧血症,PO2<60mmHg; 4、 乳酸酸中毒,Lac>3mmol/L; 5、 活动性感染; 6、 不能配合的患者; 7、 妊娠或哺乳期女性; 8、 1月内使用的钙剂、降磷药物、维生素D及其类似物、西那卡塞等剂量不稳定; 9、 严重心律失常患者; 

Exclusion criteria:

1. severe liver damage: TBIL ≥ 60umol / L; 2. uncorrectable hypotension <90/60mmHg (tissue hypoperfusion or circulatory disorder); 3. hypoxemia, PO2 <60mmHg; 4. lactic acidosis, Lac> 3mmol / L; 5. Active infections; 6. patients who can not cooperate; 7. Pregnant or lactating women; 8. Calcium, phosphorus-lowering drugs, vitamin D and its analogues, and cinacalcet used in January are unstable; 9. Patients with severe arrhythmia. 

研究实施时间:

Study execute time:

From2019-12-01To 2020-07-01 

干预措施:

Interventions:

组别:

枸橼酸抗凝组

样本量:

30

Group:

Group 1

Sample size: