ChiCTR2500115524 版本V1.0 版本创建时间2025/12/28 20:06:36 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：

ChiCTR2500115524 

最近更新日期：

Date of Last Refreshed on：

2025-12-28 20:06:31 

注册时间：

Date of Registration：

2025-12-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阶梯式肠内营养方式对重症脑卒中患者胃肠功能及营养状况的影响

Public title：

The impact of stepwise enteral nutrition on gastrointestinal function and nutritional status in patients with severe stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阶梯式肠内营养方式对重症脑卒中患者胃肠功能及营养状况的影 响

Scientific title：

The effects of stepwise enteral nutrition on gastrointestinal function and nutritional status in patients with severe stroke.

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：

苏尹 

研究负责人：

苏尹 

Applicant：

Su Yin 

Study leader：

Su Yin 

申请注册联系人电话：

Applicant telephone：

+86 10 8513 6181

研究负责人电话：

Study leader's telephone：

+86 10 8513 6181

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：

suyin3349@bjhmoh.cn

研究负责人电子邮件：

Study leader's E-mail：

suyin3349@bjhmoh.cn

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：

北京市东城区东单大华路 1 号北京医院C08病房

研究负责人通讯地址：

北京市东城区东单大华路 1 号北京医院C08病房

Applicant address：

Ward C08, Beijing Hospital, No. 1, Dongdan Dahua Road, Dongcheng District, Beijing

Study leader's address：

Ward C08, Beijing Hospital, No. 1, Dongdan Dahua Road, Dongcheng District, Beijing

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：

北京医院

Applicant's institution：

Beijing Hospital

研究负责人所在单位：

北京医院

Affiliation of the Leader：

Beijing 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：

2025BJYYEC-KY373-02

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：

北京医院伦理委员会

Name of the ethic committee：

Beijing Hospital Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-25 00:00:00

伦理委员会联系人：

侯文静

Contact Name of the ethic committee：

Hou Wenjing

伦理委员会联系地址：

北京市东城区东单大华路 1 号

Contact Address of the ethic committee：

No. 1, Dongdan Dahua Road, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 8513 8522

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：

北京医院

Primary sponsor：

Beijing Hospital

研究实施负责（组长）单位地址：

北京市东城区东单大华路 1 号

Primary sponsor's address：

No. 1, Dongdan Dahua Road, Dongcheng District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京医院

具体地址：

北京市东城区东单大华路 1 号

Institution
hospital：

Beijing Hospital

Address：

No. 1, Dongdan Dahua Road, Dongcheng District, Beijing

经费或物资来源：

无

Source(s) of funding：

none

Target disease：

Severe stroke

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过文献研究、临床实践及小组讨论确定两种肠内营养液输注方式方案。 采用随机对照研究、评估者盲法，将重症脑卒中肠内营养患者分成经胃管分次喂养组、经三腔喂养管阶梯式喂养组，比较两种喂养方式喂养不耐受的发生率、营养参数差别及效果。国内既往研究中三腔喂养管胃管端以减压作用为主，并未关注置管后胃功能的恢复，本研究所采用的阶梯式喂养为双阶梯制，胃管端采用升阶梯方式，在患者不发生胃排空延迟的前提下逐渐增加肠内营养液喂养量，促进患者胃排空，锻炼患者胃功能，减少胃废用性的发生。肠管端采用降阶梯方式，帮助患者逐渐恢复正常生理状态，提升患者预后生存质量。  

Objectives of Study：

Two enteral nutrition infusion methods were determined through literature review, clinical practice, and group discussions. A randomized controlled trial with assessor blinding was conducted, dividing critically ill stroke patients into a group receiving fractionated feeding via a gastric tube and a group receiving step-down feeding via a three-lumen feeding tube. The incidence of feeding intolerance, differences in nutritional parameters, and efficacy were compared between the two methods. Previous domestic studies primarily focused on decompression at the gastric end of the three-lumen feeding tube, neglecting the recovery of gastric function after placement. This study employed a two-step step-down feeding system: an ascending step at the gastric tube end to gradually increase the enteral nutrition volume without delaying gastric emptying, promoting gastric emptying, exercising gastric function, and reducing gastric disuse. A descending step at the intestinal end helps patients gradually return to normal physiological function, improving their prognosis and quality of life.

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.年龄>=18岁； 2.符合2019年中国各类主要脑血管病诊断要点的诊断标准，均经头颅CT或MRI证实有急性脑卒中病变； 3.急性发病，在发病24 h内入院； 4.入院时美国国立卫生研究院卒中量表（National Institute of Health Stroke Scale,NIHSS）评分>17分或格拉斯哥昏迷量表（Glasgow Coma Scale,GCS）评分<=8分。

Inclusion criteria

1. Age >=18 years; 2. Meets the diagnostic criteria of the 2019 Chinese guidelines for the diagnosis of various major cerebrovascular diseases, and is confirmed by head CT or MRI to have acute stroke lesions; 3. Acute onset, admitted to the hospital within 24 hours of onset; 4. At the time of admission, the National Institutes of Health Stroke Scale (NIHSS) score is >=17 or the Glasgow Coma Scale (GCS) score is <=8.

排除标准：

1.存在肠梗阻、消化道严重器质性病变或应激性出血等肠内营养支持治疗禁忌证； 2.严重肝肾功能不全、恶病质、白血病患者等。

Exclusion criteria：

1. Patients with contraindications to enteral nutrition support therapy, such as intestinal obstruction, severe organic lesions of the digestive tract, or stress bleeding; 2. Patients with severe liver or kidney dysfunction, cachexia, or leukemia.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

47

Group：

control group

Sample size：

干预措施：

喂养方式:胃管分次喂养 采用 25~30 kcal·kg-1·d-1估算每日肠内营养液总量，将总量分四次顿服方式通过鼻胃管给予患者肠内营养，药物及温水间歇性鼻饲，每次鼻饲前回抽胃液，确定有无胃粘膜病变及潴留 异常处理: 如出现胃粘膜病变及潴留，胃残余量超过250ml遵医嘱减量或改为肠外营养。

干预措施代码：

Intervention：

Feeding method: Frequent feeding via nasogastric tube Estimate the total daily enteral nutrition solution volume at 25-30 kcal·kg-1·d-1. Divide this volume into four single doses and administer enteral nutrition, medications, and warm water intermittently via nasogastric tube. Before each feeding, aspirate gastric fluid to check for gastric mucosal lesions and retention. Management of abnormalities: If gastric mucosal lesions or retention occur, and the gastric residual volume exceeds 250 ml, reduce the dosage as prescribed or switch to parenteral nutrition.

Intervention code：

组别：

试验组

样本量：

47

Group：

experimental group

Sample size：

干预措施：

喂养方式: 三腔喂养管阶梯式喂养 在中国成人患者肠外肠内营养临床应用指南（2023版）指出，若患者的总能量无法测定，采用 25~30 kcal·kg-1·d-1简单实用，并与实测数值较为接近，估算的方法更为简严重创伤或重症患者，第1周提供目标能量的70%更适合创伤应激的代谢特点，以70kg患者1周内每日25~30 kcal·kg-1为例，能量应为1225kcal约为肠内营养液1000ml，为防止胃排空延迟，胃管端1周内喂养量为总量的50%。由此推算阶梯式喂养采用以下喂养方法： 1.胃管端: 肠内营养液以每次20ml间歇喂养开始，第一日总量80ml，后每日较前一日每次增加20ml，第二日总量160ml，每一日较前一日共增加80ml，以此类推，2周内达到每日鼻饲总量 2.肠管端: 每日喂养量为总量-当日胃管端喂养总量，初始喂养速率从20-30ml/h开始，根据耐受情况按预定方案递增。 胃管端监测: 每次鼻饲前回抽胃液，确定有无胃粘膜病变及潴留 异常处理: 如出现胃粘膜病变及潴留，胃残余量超过250ml立即减量或停止胃管端肠内营养，增加肠管端泵入量，使患者保证每日肠内营养总量的摄入，第二日复查胃残余量，如恢复至正常水平则继续以每次20ml间歇喂养开始。

干预措施代码：

Intervention：

Feeding method: Three-lumen feeding tube step feeding. The Clinical Application Guidelines for Parenteral and Enteral Nutrition in Adult Patients in China (2023 Edition) state that if the patient's total energy cannot be measured, 25~30 kcal·kg-1·d-1 is a simple and practical method that is close to the measured value. The estimation method is also simpler. For severely traumatized or critically ill patients, providing 70% of the target energy in the first week is more suitable for the metabolic characteristics of trauma stress. Taking a 70kg patient as an example, with 25~30 kcal·kg-1 per day for one week, the energy should be 1225 kcal, which is about 1000ml of enteral nutrition solution. To prevent delayed gastric emptying, the feeding amount at the end of the gastric tube should be 50% of the total amount in the first week. Therefore, the following step-by-step feeding method is used: 1. Gastric tube feeding: Enteral nutrition begins with intermittent feedings of 20ml each time, with a total of 80ml on the first day. Each subsequent day, the amount increases by 20ml each time, reaching 160ml on the second day, increasing by 80ml each day, and so on, until the total daily feeding volume is reached within two weeks. 2. Intestinal tube feeding: The daily feeding volume is the total volume minus the total volume fed through the gastric tube that day. The initial feeding rate starts at 20-30ml/h and is gradually increased according to the predetermined plan based on tolerance. Gastric tube monitoring: Gastric fluid is aspirated before each feeding to check for gastric mucosal lesions and retention. Abnormal management: If gastric mucosal lesions or retention occur, and the gastric residual volume exceeds 250ml, immediately reduce or stop enteral nutrition through the gastric tube and increase the intestinal tube pump intake to ensure the patient's daily total enteral nutrition intake. The gastric residual volume is checked again on the second day. If it returns to normal, the intermittent feeding of 20ml each time is resumed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Hospital

Level of the institution：

Grade III Class A

测量指标：

Outcomes：

指标中文名：

比较置管后行肠内营养2周内两组患者肠内营养不耐受的发生率

指标类型：

主要指标

Outcome：

Compare the incidence of enteral nutrition intolerance in two groups of patients within 2 weeks after catheter placement and enteral nutrition.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

比较置管后行肠内营养2周内两组患者胃窦横截面积变化情况

指标类型：

主要指标

Outcome：

The changes in the cross-sectional area of ??the gastric antrum were compared between the two groups of patients who received enteral nutrition after tube placement within 2 weeks.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

比较置管时及开始行肠内营养2周后两组患者白蛋白、前白蛋白、转铁蛋白及总蛋白的数值

指标类型：

次要指标

Outcome：

Compare the albumin, prealbumin, transferrin, and total protein levels in the two groups of patients at the time of catheter placement and two weeks after the start of enteral nutrition.

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 100 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）：

随机数字表分组：运用随机数字表将符合纳排标准并签署知情同意书的94例，重症脑卒中患者随机分到胃管分次喂养组、三腔喂养管阶梯式喂养组。

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

Random number table grouping: 94 patients with severe stroke who met the inclusion criteria and signed informed consent forms were randomly assigned to the gastric tube feeding group and the three-lumen feeding tube step feeding group using a random number table.

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：

评估者盲法

Blinding：

Blinding of assessors

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

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）：

无

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

None

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：

病例记录表

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

Case Record Form, CRF

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：

  2025-12-28 20:06:31