针刺调控对脓毒症所致肌病患者在生存效益及减缓肌肉萎缩作用的前瞻性队列研究

注册号:

Registration number:

AMCTR-OON-19000298 

注册号获得时间:

Date of releasing the registration number:

2019/10/13 14:31:34 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺调控对脓毒症所致肌病患者在生存效益及减缓肌肉萎缩作用的前瞻性队列研究 

Public title:

Effect of Acupuncture regulating macrophage polarization to alleviate sepsis-induced muscle atrophy - a prospective cohort study 

研究课题的正式科学名称:

针刺调控对脓毒症所致肌病患者在生存效益及减缓肌肉萎缩作用的前瞻性队列研究 

Scientific title:

Effect of Acupuncture regulating macrophage polarization to alleviate sepsis-induced muscle atrophy - a prospective cohort study 

研究课题代号(代码):

Study subject ID:

ACU-SIM ZYYECK(2019) 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

陈伟焘 

研究负责人:

陈伟焘 

Applicant:

Chen Wei-Tao 

Study leader:

Chen Wei-Tao 

申请注册联系人电话:

Applicant telephone:

+86 20 3658 8741 

研究负责人电话:

Study leader's telephone:

+86 20 3658 8741 

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:

13924183501@139.com 

研究负责人电子邮件:

Study leader's E-mail:

13924183501@139.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:

中国广东省广州市机场路16号广州中医药大学第一附属医院8号楼8楼重症医学科二区 

研究负责人通讯地址:

中国广东省广州市机场路16号广州中医药大学第一附属医院8号楼8楼重症医学科二区 

Applicant address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, 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:

广州中医药大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

广州中医药大学第一附属医院重症医学科 

Primary sponsor:

Department of Intensive Care Unit, the First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

中国广东省广州市机场路16号广州中医药大学第一附属医院8号楼8楼重症医学科一区 

Primary sponsor's address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

中国广东省广州市机场路16号广州中医药大学第一附属医院

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

16 Jichang Road, Baiyun District, Guangzhou, Guangdong, China

经费或物资来源:

广东省中医药局课题面上项目(项目编号:20192018);广州中医药大学第一附属医院“创新强院”工程科研系列-青年科研人才培优项目(项目编号:2017QN05) 

Source(s) of funding:

Fund of Guangdong Provincial Traditional Chinese Medicine Bureau Research Project, China (20192018), Foundation of Innovative Development Project (2017QN05) 

研究疾病:

脓毒症相关肌肉萎缩 

Target disease:

Sepsis-induced myopathy 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

主要目的:比较治疗组间重复测量的脓毒症肌肉萎缩患者超声下股直肌肌肉横截面积的变化率(入ICU当天、第3天、第5天、第7天、第10天、第14天,或转出ICU时)、Time to Event 的发生率【事件的定义为:全因死亡,或非计划因有创通气而重入 ICU,(入ICU第28天、90天、六个月、一年)】。 次要目的:比较治疗组间血清肌抑素表达水平【入ICU当天、第7天,第14天(或转出ICU时)】、受试者MRC-SS评分(首次清醒时、转出ICU时)、功能独立性评分量表中的运动功能评分(入ICU第28天、90天、六个月、一年)、健康相关生活质量评分(接受ICU治疗后1年内)、ICU停留天数、住院天数、有创/无创机械通气时长、是否非计划重返ICU、重返ICU的次数、是否重入院、重入院的次数的差异。 

Objectives of Study:

Primary outcome: Comparing the rate of change of cross-sectional area of the rectus femoris muscle under ultrasound in patients with sepsis muscle atrophy between treatment groups (day 1 of ICU admission, day 3, day 5, day 7, day 14, or the time of discharge from ICU). And the incidence of Time to Event. (The events are defined as: all-cause death, or unplanned re-admission to ICU due to invasive ventilation (day 28, day 90, six month, or one year after the admission of ICU). Secondary outcome: Comparing the expression levels of serum myostatin (day 1 of ICU admission, day 7, day 14, or the time of discharge from ICU); the MRC-SS score (the first time of awaken, the time of discharge from ICU) and the motor function scores in the Functional Independence Rating Scale (day 28, day 90, six month, one year after the admission of ICU); health-related quality of life score (within 1 year after ICU treatment), ICU length of stay, length of in-hospital stay, duration of invasive/non-invasive mechanical ventilation, event of unplanned re-admission to ICU and the times of re-entered the ICU, event of re-admission of hospital and the times of re-admission of hospital between the groups. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1.年龄18至85岁; 2.符合脓毒症3.0的标准(脓毒症定义为在最初的24h内感染+SOFA≥2分); 3.第一次入住ICU,且预计在最初的48小时内存活; 4.患者或直系亲属(或法定代理人)签署知情同意书; 5. ICU入院后股直肌横截面积(RFcsa)下降超过9.24%; 6. ICU住院期间存活。 

Inclusion criteria

1. Aged 18 to 85 years old; 2. Meet the criteria of Sepsis-320which define sepsis as infection + SOFA >=2 points within the first 24 hour; 3. The first time admitted to ICU and expect to survive within the first 48 hours; 4. Informed consent signed by the patient or immediate family member (next to kin); 5. The Rectus Femoris cross-sectional area (RFcsa) decreased more than 9.24%21 after ICU admission; 6. Survival within ICU stay. 

排除标准:

1.确诊妊娠或尿β-HCG试验阳性; 2.由于认知异常,问卷(MRC-SS,FIM,知情同意书)无法完成; 3.入院即有新诊断的原发性神经肌肉疾病; 4.腿部截肢、骨盆/股骨骨折或膝关节/髋关节置换术导致无法完成RFcsa测量的患者; 5.营养不良(BMI低于18.5 kg / m^2)或恶病质; 6.患转移性肿瘤(PD)或正在进行的化疗的患者; 7.心肺呼吸骤停或短期死亡的患者; 8.长期接受皮质激素治疗的患者; 9.脓毒症发生前不能独立行走的患者; 10. ICU住院时间<7天; 11.入ICU前5天已发生脓毒症; 12.拒绝治疗和拒绝签署知情同意。 

Exclusion criteria:

1. A confirmed positive result of pregnancy or urine beta-HCG test; 2. The questionnaire(MRC-SS/FIM/consent form) could not be completed due to cognitive abnormalities; 3. A newly diagnosed primary neuromuscular disease when admitted to the hospital; 4. Patients who have leg amputationpelvic/femoral fractures or knee/hip replacement that could not complete the measure of RFcsa; 5. Malnutrition (BMI less than 18.5 kg/m2) or cachexia; 6. Patients with metastatic tumors (PD) or ongoing chemotherapy; 7. Patients with cardiorespiratory arrest or imminent death 8. Patients with long-term corticoid treatment; 9. Can't walk independently before sepsis onset; 10. ICU length of stay <7 days; 11.Sepsis has been onset more than 5 days before ICU admission; 12. Therapy withdrawal and consent refusal. 

研究实施时间:

Study execute time:

From2019-10-01To 2019-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

49

Group:

Experimental group

Sample size:

干预措施:

针刺+标准治疗

干预措施代码:

Intervention:

acupuncture+basic treatment

Intervention code:

组别:

对照组

样本量:

49

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

basic treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

股直肌横截面积

指标类型:

主要指标 

Outcome:

rectus femoris cross-sectional area

Type:

Primary indicator 

指标中文名:

Time to Event 的发生率

指标类型:

主要指标 

Outcome:

Incidence of Time to Event

Type:

Primary indicator 

指标中文名:

血清肌抑素表达水平

指标类型:

主要指标 

Outcome:

expression levels of serum myostatin

Type:

Primary indicator 

指标中文名:

MRC-SS评分

指标类型:

主要指标 

Outcome:

MRC-SS score

Type:

Primary indicator 

指标中文名:

健康相关生活质量评分

指标类型:

主要指标 

Outcome:

Functional Independence Measure

Type:

Primary indicator 

指标中文名:

ICU停留天数

指标类型:

次要指标 

Outcome:

ICU maintain days

Type:

Secondary indicator 

指标中文名:

住院天数

指标类型:

次要指标 

Outcome:

days of hospital stay

Type:

Secondary indicator 

指标中文名:

有创/无创机械通气时长

指标类型:

次要指标 

Outcome:

duration of invasive/non-invasive mechanical ventilation

Type:

Secondary indicator 

指标中文名:

是否重入ICU

指标类型:

次要指标 

Outcome:

case of re-entered the ICU

Type:

Secondary indicator 

指标中文名:

重入ICU的次数

指标类型:

次要指标 

Outcome:

times of re-entered the ICU

Type:

Secondary indicator 

指标中文名:

是否重入院

指标类型:

次要指标 

Outcome:

case of re-admission of hospital

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

外周血

Sample Name:

Blood

Tissue:

Peripheral blood

人体标本去向

使用后保存 

说明

保存于生物样本库,保存时限半年

Fate of sample:

Preservation after use 

Note:

kept in the Biomedical Research Library at Lingnan Medical Research Center for half a year

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 years

随机方法(请说明由何人用什么方法产生随机序列):

研究为前瞻性队列研究,不采用随机分组方法。受试者达到研究纳入标准后,24小时内由ICU主诊医师根据诊疗常规及征求患者/直系家属治疗意愿后评估是否接受针刺治疗;研究者不干预该过程

性别:

男女均可

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

This study was a prospective cohort study and did not use a randomized approach. After the subjects met the study inclusion criteria, the ICU attending physician assessed the acupuncture treatment within 24 hours based on the treatment routine and the willingness of the patient/direct family to be treated

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

原始数据在论文发表后通过通讯作者获得

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

The data can be obtained by the corresponding author after the paper's publishment

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

根据本研究所用的数据采集方法,本临床研究方案中使用的病例报告表(CRF)是纸质版CRF表格及应用EDC系统填写的电子数据记录表。需使用CRF并完成每例入选受试者的表格。完成的CRF数据属于广州中医药大学第一附属医院重症医学科,除非本科的授权代表或相关法规监管部门,未经书面许可,在任何情况下均不可提供给第三方使用。研究者将最终负责收集和报告所有临床数据,并保证这些数据的准确性、可靠性/原始性、归属性、完整性、一致性、清晰性、及时性(同时性)、持久性以及可获得性。CRF必须有研究者或一名经授权的工作人员签字,以证明CRF中记录的信息的真实性。对CRF或原始文件中的内容所做的任何修正,都必须在原有内容处注明日期、更改人的姓名首字母和解释说明(如有必要),而且原有内容应清晰可辨。原始文件将是医院或医生记录的受试者病例,记录在CRF中的信息必须与这些病例一致。 为保证监查员的评价和/或稽查,研究者应保存记录,包括所有参加研究受试者的身份(有充分的信息与记录链接,例如:CRF和医院病历)、所有签名的知情同意书原件、所有CRF副本、安全性报告表、原始文件、治疗处置的详细记录。研究者对记录的保存实现应以国际协调会议(ICH)、当地法规或临床研究协议(CSA)三者中规定的最长时限为准。如果研究者由于任何原因在规定的期限内不能继续保留研究记录(例如:退休、工作调动等),研究记录必须转交给一名主要研究者认可的指定人员(如:研究者指派的独立第三方)。研究者记录必须在研究完成或终止后至少保存15年,或按照使用的当地法规要求保存更长时间。 临床研究将根据风险大小制定相应的数据安全监察计划。所有不良事件均详细记录,恰当处理并追踪直到妥善解决或病情稳定,按照规定及时向伦理委员会、主管部门、申办者和药品监督管理部门报告严重不良事件与非预期事件等;主要研究者定期对所有不良事件进行累积性回顾,必要时召开研究者会议评估研究的风险与受益;双盲试验必要时可以进行紧急揭盲,以确保受试者安全与权益;大于最小风险的研究将安排独立的数据监查员对研究数据进行监查,高风险研究将建立独立的数据安全监察委员会对累积的安全性数据以及有效性数据进行监查,以做出研究是否继续进行的建议

The repository and management of the data(Please specify what repository will be used for management of the metadata):

According to the data collection method designed for this study, the case report form (CRF) used in this clinical research program is a paper version of the CRF form and an electronic data record form filled in by the EDC system. A CRF is required and a table of each candidate is completed. The completed CRF data belongs to the Department of Critical Care Medicine of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine. Unless authorized by the undergraduate or relevant regulatory authorities, it may not be provided to third parties under any circumstances without written permission. The investigator will ultimately be responsible for collecting and reporting all clinical data and ensuring the accuracy, reliability/originality, attribution, completeness, consistency, clarity, timeliness (simultaneity), persistence and availability of such data. The CRF must be signed by a researcher or an authorized staff member to demonstrate the authenticity of the information recorded in the CRF. Any amendments made to the contents of the CRF or the original document must be dated, changed in the initials and explanations (if necessary), and the original content should be legible. The original document will be the subject case recorded by the hospital or doctor, and the information recorded in the CRF must be consistent with these cases. In order to ensure the auditor's evaluation and/or audit, the researcher should keep records, including the identity of all participating study subjects (with sufficient information and record links, such as: CRF and hospital medical records), original copy of all signed informed consent, detailed records of all CRF copies, safety report forms, original documents, and treatment disposition. The investigator's preservation of records should be based on the maximum timeframe specified in the International Conference on Harmonization (ICH), local regulations, or Clinical Study Agreement (CSA). If the researcher is unable to retain the research record for any reason (e.g., retirement, job transfer, etc.) for any reason, the research record must be forwarded to a designated person recognized by a principal investigator (e.g., an independent third party appointed by the investigator ). The investigator's record must be kept for at least 15 years after the study is completed or terminated, or for a longer period by local regulations used. Clinical research will develop a corresponding data safety monitoring plan based on the size of the risk. All adverse events are recorded in detail, properly processed and followed until properly resolved or the condition is stable, and timely report serious adverse events and unanticipated events to the ethics committee, competent authorities, sponsors and drug regulatory authorities in accordance with regulations; the main investigator conducts a cumulative review of all adverse events on a regular basis, and if necessary, convene a meeting of researchers to assess the risks and benefits of the study; double-blind trials can be performed on emergency blindness as necessary to ensure the safety and rights of the subjects; research that is greater than the minimum risk will arrange for an independent data monitor to monitor the research data. The high-risk study will establish an independent data security oversight committee to monitor accumulated safety data and effectiveness data to make recommendations for research to continue

创建人:

Creater Name:

 2019-10-13
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