ChiCTR2400085389 版本V1.0 版本创建时间2024/06/06 11:12:21 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：

 ChiCTR2400085389 

最近更新日期：

Date of Last Refreshed on：

 2024-06-06 11:12:14 

注册时间：

Date of Registration：

 2024-06-06 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

超声鼻烟壶阻力指数在脓毒症休克血流动力学评估的临床意义和作用

Public title：

Clinical significance and role of ultrasonic snuff bottle resistance index in hemodynamic evaluation of septic shock

注册题目简写：

English Acronym：

研究课题的正式科学名称：

超声鼻烟壶阻力指数在脓毒症休克血流动力学评估的临床意义和作用

Scientific title：

Clinical significance and role of ultrasonic snuff bottle resistance index in hemodynamic evaluation of septic shock

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：

徐真珍 

研究负责人：

徐真珍 

Applicant：

Zhenzhen Xu 

Study leader：

Zhenzhen Xu 

申请注册联系人电话：

Applicant telephone：

 +86 158 3269 2143

研究负责人电话：

Study leader's
telephone：

+86 158 3269 2143

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：

 619468650@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 619468650@qq.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：

河北省张家口市宣化区清远路92号

研究负责人通讯地址：

河北省张家口市宣化区清远路92号

Applicant address：

No.92 Qingyuan Road, Xuanhua District, Zhangjiakou City, Hebei Province

Study leader's address：

No.92 Qingyuan Road, Xuanhua District, Zhangjiakou City, Hebei Province

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：

河北北方学院附属第二医院

Applicant's institution：

The Second Affiliated Hospital of Hebei North University

研究负责人所在单位：

河北北方学院附属第二医院

Affiliation of the Leader：

The Second Affiliated Hospital of Hebei North 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：

 2023-07-08

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：

河北北方学院附属第二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Hebei North University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-07-18 00:00:00

伦理委员会联系人：

陈云飞

Contact Name of the ethic committee：

Yunfei Chen

伦理委员会联系地址：

河北省张家口市宣化区清远路92号

Contact Address of the ethic committee：

No.92 Qingyuan Road, Xuanhua District, Zhangjiakou City, Hebei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 180 3139 2945

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：

河北北方学院附属第二医院

Primary sponsor：

The Second Affiliated Hospital of Hebei North University

研究实施负责（组长）单位地址：

河北省张家口市宣化区清远路92号

Primary sponsor's address：

No.92 Qingyuan Road, Xuanhua District, Zhangjiakou City, Hebei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

河北省

市(区县)：

Country：

China

Province：

Hebei Province

City：

单位(医院)：

河北北方学院附属第二医院

具体地址：

河北省张家口市宣化区清远路92号

Institution
hospital：

The Second Affiliated Hospital of Hebei North University

Address：

No.92 Qingyuan Road, Xuanhua District, Zhangjiakou City, Hebei Province

经费或物资来源：

自筹

Source(s) of funding：

self-finance

研究疾病：

脓毒症休克  

Target disease：

Septic shock

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

脓毒症被定义为宿主对感染免疫失调引起的严重器官损伤，而脓毒症休克被定义为导致持续低血压的进展，需要血管加压药来维持足够的组织灌注，是入住重症监护病房 (ICU) 的常见原因，并且具有高发病率和死亡率 。脓毒症休克的主要特征是外周血管阻力异常； 因此，改善血管功能和器官损伤对于脓毒症休克的管理非常重要。血管活性药物的及时应用，可改善脏器微循环状态，明显提高有效循环血量，纠正脓毒症休克中高排低阻的状态。去甲肾上腺素以通过收缩外周血管或者提高心排量以升高血压，改善重要脏器灌注和循环，有效减轻脏器损害。脓毒症指南指出: 缩血管药物治疗的初始目标是 MAP 达 到 65mmHg；但是经验告诉我们，组织的血流灌流比单纯的血压维持更重要；因此，评估区域灌注对治疗感染性休克更有益。本课题通过对鼻烟壶阻力指数监测，探讨其在脓毒症休克血流动力学评估的临床意义和作用。 脓毒症休克属分布性休克，除感染导致 SIRS 外，还常因动静脉扩张及血浆外渗而引起有效循环血容量的降低，并由于微循环的广泛扩张导致外周血管阻力降低，心排血量正常或增加，心率加快，肺动脉氧合升高，其间相互影响，最终引起能量耗竭、代谢产物蓄积、肾上腺素能失敏及细胞因子( 一氧化氮、内皮素) 活化，并进一步导致血管平滑肌细胞收缩功能衰退、微循环广泛扩张。经验显示，单纯依赖液体复苏治疗很难纠正脓毒症休克患者的低血压状态，相反，若液体复苏过程中液体过度输注，还会不可避免地加重毛细血管渗漏及组织循环障碍，并导致肺水肿和腹腔高压，进一步加重原有的组织灌注障碍。而血管活性药物的及时应用，可改善脏器微循环状态，明显提高有效循环血量，纠正脓毒症休克中高排低阻的状态。去甲肾上腺素以通过收缩外周血管或者提高心排量以升高血压，改善重要脏器灌注和循环，有效减轻脏器损害。但是升高血压并不是治疗的最终目的，改善器官灌注才是临床医生应该关注的关键。一味地追求达到较高水平的血压对改善患者预后并无益处，应用不当血管过度收缩也可引起脏器灌注不足，加重脏器损害及增加多器官功能障碍综合征 ( multiple organ dysfunction syndrome，MODS) 的发生。因此，在治疗过程中合理的调整血管活性药物的用量尤为重要。 随着超声技术在重症医学中的发展，超声检测外周血流量越来越受到重视。 与中心循环相比，外周循环更接近于组织灌注和微循环。外周血管阻力可能会因生理差异或病理状况而改变。电阻指数 (RI)是在多普勒超声检查中表征动脉波形的常用参数。 多普勒鼻烟壶阻力指数 (SBRI) 已被证明是评估血管阻力和血管顺应性的可行且准确的参数，且 SBRI 与全身血管阻力指数 (SVRI) 之间存在很强的相关性。在脓毒症休克治疗过程中依据SBRI调整血管活性药物的用量可在保证组织灌注的同时避免血管过度收缩，减少并发症的发生。通PUBMED检索关键词“鼻烟壶阻力指数”与“脓毒症休克”没有相关文章。  

Objectives of Study：

Sepsis is defined as the severe organ damage caused by the host's immune disorder to infection, while septic shock is defined as the progression of persistent hypotension, which requires vasopressors to maintain adequate tissue perfusion. It is a common cause of admission to intensive care unit (ICU) and has high morbidity and mortality. The main feature of septic shock is abnormal peripheral vascular resistance; Therefore, improving vascular function and organ damage is very important for the management of septic shock. The timely application of vasoactive drugs can improve the microcirculation of organs, obviously increase the effective circulating blood volume and correct the state of high output and low resistance in septic shock. Norepinephrine can raise blood pressure, improve perfusion and circulation of important organs and effectively reduce organ damage by contracting peripheral blood vessels or increasing cardiac output. Sepsis guidelines point out that the initial goal of vasoconstrictor drug therapy is to achieve MAP of 65mmHg;; But experience tells us that tissue perfusion is more important than simple blood pressure maintenance; Therefore, it is more beneficial to evaluate regional perfusion in the treatment of septic shock. Through monitoring the resistance index of snuff bottle, this paper discusses its clinical significance and role in hemodynamic evaluation of septic shock. Septic shock belongs to distributed shock. Besides SIRS caused by infection, the effective circulating blood volume is often reduced due to arteriovenous dilatation and plasma extravasation. Due to the extensive expansion of microcirculation, the peripheral vascular resistance is reduced, the cardiac output is normal or increased, the heart rate is accelerated, and the pulmonary artery oxygenation is increased. The interaction between them eventually leads to energy depletion, accumulation of metabolites, adrenergic desensitization and activation of cytokines (nitric oxide and endothelin), and further leads to the contraction function decline of vascular smooth muscle cells. Experience shows that it is difficult to correct the hypotensive state of septic shock patients only by relying on fluid resuscitation. On the contrary, if fluid is over-infused during fluid resuscitation, it will inevitably aggravate capillary leakage and tissue circulation disorder, and lead to pulmonary edema and abdominal hypertension, further aggravating the original tissue perfusion disorder. The timely application of vasoactive drugs can improve the microcirculation of organs, obviously increase the effective circulating blood volume and correct the state of high output and low resistance in septic shock. Norepinephrine can raise blood pressure, improve perfusion and circulation of important organs and effectively reduce organ damage by contracting peripheral blood vessels or increasing cardiac output. But raising blood pressure is not the ultimate goal of treatment, and improving organ perfusion is the key that clinicians should pay attention to. Pursuing a higher level of blood pressure blindly is not beneficial to improve the prognosis of patients. Improper application of excessive vasoconstriction can also lead to insufficient organ perfusion, aggravate organ damage and increase the occurrence of multiple organ dysfunction syndrome (MODS). Therefore, it is particularly important to reasonably adjust the dosage of vasoactive drugs during the treatment. With the development of ultrasonic technology in critical care medicine, ultrasonic detection of peripheral blood flow has been paid more and more attention. Compared with central circulation, peripheral circulation is closer to tissue perfusion and microcirculation. Peripheral vascular resistance may change due to physiological differences or pathological conditions. Resistance index (RI) is a commonly used parameter to characterize arterial waveform in Doppler ultrasound examination. Doppler snuff bottle resistance index (SBRI) has been proved to be a feasible and accurate parameter to evaluate vascular resistance and vascular compliance, and there is a strong correlation between SBRI and systemic vascular resistance index (SVRI). During the treatment of septic shock, adjusting the dosage of vasoactive drugs according to SBRI can ensure tissue perfusion and avoid excessive contraction of blood vessels and reduce complications. Through PUBMED search, the keyword "snuff bottle resistance index" and "septic shock" have no related articles.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

符合2021脓毒症或脓毒症休克诊断标准。临床资料完整，存在明确感染；患者及家属知情同意；年龄≥18 岁。

Inclusion criteria

Meet the diagnostic criteria of sepsis or septic shock in 2021. The clinical data is complete and there is definite infection; Informed consent of patients and their families; Age ≥18 years old.

排除标准：

肝、肾功能衰竭者；合并恶性肿瘤者；入院时存在多器官功能障碍综合征 （Multiple Organ Dysfunction Syndrome, MODS）者； 伴精神疾病者；哺乳期或妊娠期女性。

Exclusion criteria：

Liver and renal failure; Patients with malignant tumor; Patients with multiple organ dysfunction syndrome (MODS) at the time of admission; People with mental illness; Lactating or pregnant women.

研究实施时间：

Study execute time：

从 From 2023-09-01 00:00:00至 To 2026-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-09-01 00:00:00 至 To 2025-09-01 00:00:00

干预措施：

Interventions：

组别：

超声指导组

样本量：

 50

Group：

Ultrasound guidance group

Sample size：

干预措施：

按照2021脓毒症指南的标准进行综合治疗，通过SBRI监测外周血管阻力，依据外周血管阻力变化调整血管活性药物用量，维持鼻烟壶阻力指数（SBRI）于0.91-101之间。

干预措施代码：

Intervention：

Comprehensive treatment was carried out according to the standard of 2021 Sepsis Guidelines. Peripheral vascular resistance was monitored by SBRI, and the dosage of vasoactive drugs was adjusted according to the change of peripheral vascular resistance, and the snuff bottle resistance index (SBRI) was maintained at 0.91-101.

Intervention code：

组别：

对照组

样本量：

 50

Group：

control group

Sample size：

干预措施：

按照2021脓毒症指南的标准进行综合治疗，依据脓毒症休克指南调整血管活性药物用量，维持MAP> 65 mmHg。

干预措施代码：

Intervention：

Comprehensive treatment was carried out according to the standards of 2021 sepsis guidelines, and the dosage of vasoactive drugs was adjusted according to sepsis shock guidelines to maintain MAP> 65 mmHg.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

China

Province：

Hebei Province

City：

单位(医院)：

 河北北方学院附属第二医院 

单位级别：

 三级 

Institution
hospital：

The Second Affiliated Hospital of Hebei North University

Level of the institution：

three-level

测量指标：

Outcomes：

指标中文名：

鼻烟壶阻力指数

指标类型：

主要指标

Outcome：

Snuff bottle resistance index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心输出量

指标类型：

次要指标

Outcome：

Cardiac output

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

外周血管阻力

指标类型：

次要指标

Outcome：

Peripheral vascular resistance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

平均动脉压

指标类型：

次要指标

Outcome：

Mean arterial pressure

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肌酐

指标类型：

次要指标

Outcome：

Creatinine

Type：

Secondary indicator

测量时间点：

creatinine

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

氧合指数

指标类型：

次要指标

Outcome：

Oxygenation index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血乳酸

指标类型：

次要指标

Outcome：

Blood lactic acid

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

降钙素原

指标类型：

次要指标

Outcome：

Procalcitonin

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

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）：

由研究者通过计算机产生随机数字表，规定随机数字为奇数的研究对象分到试验组，偶数分到对照组。

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

The researchers generated a random number table by computer, and the subjects with odd numbers were assigned to the experimental group and even numbers to the control group.

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：

单盲（对受试者隐藏分组），对评估者不隐藏分组

Blinding：

Single blinded (grouping is hidden from subjects), and grouping is not hidden from evaluators.

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）：

临床试验公共管理平台 IPD（http://www.medresman.org.cn）。不共享

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

ResMan IPD (http://www.medresman.org.cn) . N/A

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：

数据采集以手写方式记录，本研究不涉及电子管理方式。

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

Data collection is recorded by handwriting, and this study does not involve electronic management.

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：

  2024-06-06 11:12:14