中药甘遂鼻肠营养管给药治疗重症急性胰腺炎腹腔高压的随机对照研究

注册号:

Registration number:

ITMCTR2024000034

最近更新日期:

Date of Last Refreshed on:

2024-03-21

注册时间:

Date of Registration:

2024-03-21

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

中药甘遂鼻肠营养管给药治疗重症急性胰腺炎腹腔高压的随机对照研究

Public title:

A randomized controlled study on the treatment of severe acute pancreatitis with intraperitoneal hypertension through nasogastric nutrition tube administration of Gansui

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中药甘遂鼻肠营养管给药治疗重症急性胰腺炎腹腔高压的随机对照研究

Scientific title:

A randomized controlled study on the treatment of severe acute pancreatitis with intraperitoneal hypertension through nasogastric nutrition tube administration of Gansui

研究课题的正式科学名称简写:

Scientific title acronym:

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:

沈展涛

研究负责人:

沈展涛

Applicant:

zhantao shen

Study leader:

zhantao shen

申请注册联系人电话:

Applicant telephone:

13535337248

研究负责人电话:

Study leader's telephone:

13535337248

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:

gzgentle@foxmail.com

研究负责人电子邮件:

Study leader's E-mail:

gzgentle@foxmail.com

申请单位网址(自愿提供):

Study leader's 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:

广州市大德路111号广东省中医院

研究负责人通讯地址:

广州市大德路111号广东省中医院

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

申请注册联系人邮政编码:

Applicant postcode:

510120

研究负责人邮政编码:

Study leader's postcode:

510120

申请人所在单位:

广东省中医院

Applicant's institution:

Guangdong Provincial Hospital of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

YF2022-228-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

广东省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/8/1 0:00:00

伦理委员会联系人:

李晓彦

Contact Name of the ethic committee:

Xiaoyan Li

伦理委员会联系地址:

中国广东省广州市越秀区大德路111号

Contact Address of the ethic committee:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

02081887233

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llbgs@gzucm.edu.cn

研究实施负责(组长)单位:

广东省中医院

Primary sponsor:

Guangdong Provincial Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

广东省中医院

Primary sponsor's address:

Guangdong Provincial Hospital of Chinese Medicine

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

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广东省中医院

具体地址:

中国广东省广州市越秀区大德路111号

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou City, Guangdong Province, China

经费或物资来源:

博士研究生课题,无经费

Source(s) of funding:

none

研究疾病:

重症急性胰腺炎

研究疾病代码:

Target disease:

severe acute pancreatitis

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

观察甘遂通过鼻空肠营养管途径下给药对重症急性胰腺炎(Severe acute pancreatitis, SAP)患者腹内压(Intra-abdominal pressure, IAP)的临床疗效及其安全性,从而为SAP患者腹腔高压(Intra-abdominal hypertension, IAH)、腹腔间隔室综合征(Abdominal compartment syndrome, ACS)的早期干预、治疗提供新的思路。

Objectives of Study:

The purpose of this study is to observe the clinical efficacy and safety of Gansui, which is administrated through nasogastric nutrition tube, in treating severe acute pancreatitis (SAP) patients with intra-abdominal hypertension (IAH). We hope to provide new ideas for early intervention and treatment of IAH and abdominal compartment syndrome (ACS) in SAP patients.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①符合“中重症急性胰腺炎”或“重症急性胰腺炎”的诊断标准(参照2021年版中国急性胰腺炎诊治指南 [1]); ②可以通过鼻空肠营养管进行甘遂给药; ③自愿参加本研究并签署知情同意书; ④年龄≥18且≤75岁,男女不限。

Inclusion criteria

① Meets the diagnostic criteria for "moderate severe acute pancreatitis" or "severe acute pancreatitis" (refer to the 2021 edition of Chinese Guidelines for Diagnosis and Treatment of Acute Pancreatitis); ② Gansui can be administered through a nasojejacual nutrition tube; ③ Voluntarily participate in this study and sign an informed consent form; ④ Age ≥ 18 and ≤ 75 years old, regardless of gender.

排除标准:

①无消化道给药途径; ②既往有消化道大手术病史; ③目前正在参加或在本研究前1个月内参加过其它临床试验的患者; ④对治疗药物有过敏反应; ⑤有生育要求,或处于妊娠及哺乳期患者; ⑥肝功能Child-Pugh C级; ⑦肾功能CKD4期或5期。

Exclusion criteria:

① No gastrointestinal administration route; ② Have a history of major digestive surgery in the past; ③ Patients who are currently participating in or have participated in other clinical trials within the month prior to this study; ④ Allergic reactions to therapeutic drugs; ⑤ Patients with fertility requirements or those who are pregnant or breastfeeding; ⑥ Liver function: Child Pugh C-grade; ⑦ Kidney function: CKD stage 4 or 5.

研究实施时间:

Study execute time:

From 2022-09-01

To      2024-02-29

征募观察对象时间:

Recruiting time:

From 2022-09-01

To      2023-12-31

干预措施:

Interventions:

组别:

对照组

样本量:

13

Group:

control group

Sample size:

干预措施:

基础治疗+留置鼻空肠营养管

干预措施代码:

Intervention:

Basic treatment +Indwelling nasojejacual nutrition tube

Intervention code:

组别:

试验组

样本量:

13

Group:

experimental group

Sample size:

干预措施:

基础治疗+甘遂鼻空肠营养管鼻饲

干预措施代码:

Intervention:

Basic treatment + Nasal feeding of Gansui through a nasojejacual nutrition tube

Intervention code:

样本总量 Total sample size : 26

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):

广东省中医院

单位级别:

三甲

Institution/hospital:

Guangdong Provincial Hospital of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

腹腔灌注压

指标类型:

次要指标

Outcome:

Abdominal perfusion pressure

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天以及出院前,测量后分别记录,直至受试者病情稳定拔除尿管

测量方法:

腹腔灌注压(mmHg)=平均动脉压(mmHg)-腹腔内压力(mmHg)

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, and before discharge, until the patient's urinary catheter is removed.

Measure method:

Abdominal perfusion pressure=mean arterial pressure - intra-abdominal pressure

指标中文名:

住院天数

指标类型:

次要指标

Outcome:

Hospitalization days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

静脉血脂肪酶

指标类型:

次要指标

Outcome:

lipase

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

指标中文名:

住院费用

指标类型:

次要指标

Outcome:

Hospitalization expenses

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

APACHE II评分

指标类型:

次要指标

Outcome:

APACHE II score

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天以及出院前

测量方法:

参考APACHE II评分表

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment

Measure method:

Refer to the APACHE II scoring table

指标中文名:

血气分析(动脉血氧合指数、CO2 分压)

指标类型:

次要指标

Outcome:

arterial oxygenation index, CO2 partial pressure

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

指标中文名:

白细胞计数、中性粒细胞百分比

指标类型:

次要指标

Outcome:

White blood cell count, percentage of neutrophils

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

指标中文名:

ICU住院天数

指标类型:

次要指标

Outcome:

ICU hospitalization days

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:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

指标中文名:

CT严重指数评分

指标类型:

次要指标

Outcome:

CT severity index score

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

详见CT严重指数评分表,是评估SAP严重程度的重要指标,由胰腺炎性反应分值+胰腺坏死分值+胰外并发症分值组成,总分0~10分

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

refer to the CT Severity Index scoring table

指标中文名:

腹腔内压力

指标类型:

主要指标

Outcome:

intra-abdominal pressure

Type:

Primary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,测量后分别记录,直至受试者病情稳定拔除尿管。

测量方法:

膀胱测压法

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, and before discharge, until the patient's urinary catheter is removed.

Measure method:

Bladder pressure measurement method

指标中文名:

并发症发生率

指标类型:

次要指标

Outcome:

Incidence of complications

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血淀粉酶

指标类型:

次要指标

Outcome:

amylase

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

指标中文名:

腹围

指标类型:

次要指标

Outcome:

abdominal circumference

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前

测量方法:

受试者腹部过脐平面的水平周长

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment

Measure method:

The horizontal circumference of the abdominal plane passing through the navel

指标中文名:

呼吸机参数(气道平均压、气道阻力)

指标类型:

次要指标

Outcome:

Ventilator parameters (mean airway pressure, airway resistance)

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天(直至受试者停用呼吸机)

测量方法:

呼吸机读取

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment (until the patient stops using ventilator)

Measure method:

Reading data from the ventilator

指标中文名:

胃肠动力评分

指标类型:

次要指标

Outcome:

Gastrointestinal motility score

Type:

Secondary indicator

测量时间点:

治疗前,经治疗后第1、3、5、7、10天,出院前,出院后第30天

测量方法:

详见2015年广东省质量技术监督局《围手术期术后胃肠动力评价规范》。由6个评价项目组成:包括客观评价指标3个,依次为肛门排气、肛门排便、肠鸣音;主观评价指标3个,依次为腹胀痛、恶心、呕吐。观察者按主、客观指标分别对受试者情况进行评分,然后对胃肠动力进行等级评价。

Measure time point of outcome:

Before treatment, on the 1st, 3rd, 5th, 7th, and 10th day after treatment, before discharge, and on the 30th day after discharge

Measure method:

Please refer to the 2015 Guangdong Provincial Quality and Technical Supervision Bureau's "Evaluation Specification for Postoperative Gastrointestinal Motility during the Perioperative Period" for details

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:

结束

Completed

年龄范围:

最小 18
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由于例数不多,随机化方法不设限制,将纳入研究的患者按随机方法分为2组:即试验组和对照组,每组13例。具体操作如下:由研究组专人产生随机系列并分配试验对象,采用SPSS 23.0统计分析软件设置种子数,先生成一组随机数字,按1:1比例将研究对象按照事先设定随机数字分组规定分为试验组、对照组。制作随机分配卡片,用不透光信封密封,信封上写入组顺序编号,信封入组顺序编号与卡片序号相同,并按编号顺序将信封依次排好,由专人保管。按照纳入病例的先后次序对应的入组顺序号拆开信封,按信封内卡片上的规定进行分组。

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

A dedicated person is responsible for setting the number of seeds using SPSS 23.0 statistical analysis software. The participants are randomly divided into an experimental group and a control group in a 1:1 ratio. Make random allocation cards, seal them in opaque envelopes, write a number on the envelope, and the envelope number should be the same as the card number. Arrange the envelopes in order of the number and have them kept by a dedicated person. Open the envelopes in the order of inclusion of cases and group them according to the regulations on the cards inside the envelopes.

盲法:

本研究由于干预方式明显不同,除了常规基础治疗、留置鼻空肠营养管外,试验组给予甘遂,对照组不使用甘遂,患者在清醒状态下知道使用甘遂与否,故本试验无法采用盲法设计,但数据管理、统计分析人员仍然对分组及干预措施保持盲态,即不知道患者分组及所使用措施。

Blinding:

None

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,博士论文

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

2025-01-01, Doctoral Dissertation

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:

1. 数据记录与数据的可溯源性: 研究者应当如实填写病例报告表,并保证病例报告表上的内容与住院病历上的内容一致。数据应完整、正确、清晰地录入,并且与住院病历中的原始记录、检验报告核对无误,保证数据记录完整、准确、真实。 2. 数据录入与疑问管理: 由专人回收全部相关试验资料,对其做好登记与编码,对病例报告表数据进行双机双录入,做到不重不漏。对病例报告表中存在的疑问,依据原始住院病例资料,人工核查。

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

1. Data recording and traceability: Researchers should truthfully fill out the case report form and ensure that the content on the case report form is consistent with the content on the hospitalization medical record. The data should be entered completely, correctly, and clearly, and checked against the original records and inspection reports in the inpatient medical records to ensure the completeness, accuracy, and authenticity of the data records. 2. Data entry and question management: A dedicated person will collect all relevant trial data, register and code them, and perform dual machine and dual input on the case report form data to ensure no duplication or omission. For any doubts in the case report form, manual verification will be conducted based on the original inpatient case data.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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