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Status unknownNCT05454397Updated Jul 12, 2022

A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients

An observational study in Acute Stroke, sponsored by Nanfang Hospital, Southern Medical University. Status unknown at 34 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-12.

Sponsored by Nanfang Hospital, Southern Medical University · Observational

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years and older
Sex
All
01

Study summary

Stroke is the leading cause of premature death and disability, and early recognition and treatment of dysphagia is fundamental to stroke management. Early and full tube feeding in the acute phase of stroke helps to address nutritional problems resulting from dysphagia and impaired consciousness and helps to reduce morbidity and mortality and poor outcomes. Current guidelines for acute stroke management do not address the goal of tube feeding of enteral nutrition for energy and protein. In the treatment of acute stroke, there is a strong global focus on pharmacological thrombolysis or mechanical thrombolysis, with nutritional interventions being a less explored topic. Real-world evidence on large samples, feeding attainment and outcomes, and nutrition in the acute phase of stroke is lacking in China . The aim of this study was to understand the current status of nutritional therapy in stroke hospitalization in neurology and its impact on prognosis nationwide, and to improve the standardized management process of enteral nutrition therapy in the acute phase of stroke.

Read the detailed description

Malnutrition is a common geriatric syndrome with a disproportionate incidence in geriatric and neurology inpatients. In recent years, national nutritional surveys of geriatric inpatients have shown that about 2/3 of geriatric inpatients have nutritional problems; only half of neurology inpatients at high risk receive nutritional support, and inadequate nutrition exacerbates primary disease, increases complications, makes hospital stays longer, and ultimately affects patient survival outcomes.

To increase comprehensive and up-to-date research on the current status of nutritional therapy in geriatric and neurology inpatients, and to lay the foundation for future standardized treatment and standardized management, we conducted a nationwide survey on the current status of nutritional risk screening and treatment in geriatric and neurology inpatients. The aim is to raise the level of clinicians' awareness of malnutrition and nutritional risk in hospitalized patients, standardize clinical practice, and properly implement nutritional support to improve patients' clinical outcomes.

02

Conditions studied

  • Acute Stroke

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Keywords

  • Stroke; Dysphagia;Nutrition management;
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Nanfang Hospital, Southern Medical University is the lead sponsor of 480 studies on the registry; 212 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Newly admitted stroke patients admitted to the neurology unit, ≥18 years of age, within 7 days of onset, expected survival >3 months, expected neurology stay 7-10 days, and at risk of malnutrition (MUST ≥2 points) or at nutritional risk (NRS2002 ≥3 points). Patients' age, sex, hospital, hospitalization number, height, primary diagnosis on admission, and previous underlying disease were collected.

Inclusion criteria

  • Newly admitted stroke patients admitted to neurology, age ≥18 years, within 7 days of onset, expected survival >3 months (i.e., not end-stage), expected neurology stay 7-10 days;
  • At risk of malnutrition (MUST ≥ 2 points) or at nutritional risk (NRS2002 ≥ 3 points), sign an informed notice.

Exclusion criteria

Exclusion Criteria:

  • Transferred during treatment, contraindications to nutritional therapy (e.g., hemodynamic instability, gastrointestinal bleeding (bleeding >100 ml), other nutritional studies, pregnancy.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • case group

    Patients with acute stroke with nutritional risk

    Other: Observational study, no intervention

Interventions

  • OtherObservational study, no intervention

    Observational study, no intervention

06

What researchers measure

Primary outcomes

  1. Nutrition implementation rate

    Proportion of patients hospitalized for stroke who were given nutritional support

    Time frame: The first day of admission; the seventh day of admission; the day before discharge.

  2. Nutrition compliance rate of stroke inpatients

    Percentage of patients hospitalized for stroke whose nutritional indicators and nutritional status met the guidelines after being given nutritional support

    Time frame: The first day of admission; the seventh day of admission; the day before discharge.

Secondary outcomes

  1. 30-day post-discharge mortality

    Proportion of enrolled patients who died 30 days after discharge from the hospital

    Time frame: 30-day post-discharge

  2. Infection rate

    Proportion of enrolled patients with pulmonary infection 30 days after discharge from hospital.

    Time frame: 30-day post-discharge

  3. Readmission rate

    Proportion of patients enrolled who were readmitted for various reasons 30 days after discharge.

    Time frame: 30-day post-discharge

  4. Functional prognosis

    Functional prognosis of the enrolled patients, such as life skills, motor and sensory functions, cognitive functions and swallowing functions.

    Time frame: 30-day post-discharge

07

Study locations

34 of 34 sites recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, Anhui, China
    • Yajuan Hu, MD · Contact · 13956912105
    Recruiting
  • Dongfang Hospital of Beijing University of Chinese Medicine
    Beijing, Beijing, China
    • Baoxin Chen, MD · Contact · 13581546499
    Recruiting
  • The First Afilliated Hospital of Fujian Medical University
    Fuzhou, Fujian, China
    • Zhiqiang Wang, MD · Contact · 13805059300
    Recruiting
  • Zhongshan Hospital Xiamen University
    Xiamen, Fujian, China
    • Lihong Su, MD · Contact · 18060486879
    Recruiting
  • Fujian Province Zhangzhou Hospital
    Zhengzhou, Fujian, China
    • Bailing Chen, MD · Contact · 15892014859
    Recruiting
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong, China
    • JinYu Chen, MD · Contact · 568344684@qq.com
    • Suyue Pan, M.D., Ph.D. · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Guangxi Medical University
    Nanning, Guangxi, China
    • Zhijian Liang, MD · Contact · 13737944579
    Recruiting
  • The second Affiliated Hospital of Harbin Medical University
    Ha'erbin, Heilongjiang, China
    • Lihua Wang, MD · Contact · 13100881600
    Recruiting
  • Kaifeng Central Hospital
    Kai Feng, Henan, China
    • Yan Zhao, MD · Contact · 15137884148
    Recruiting
  • Henan Provincial People'S Hospital
    Zhengzhou, Henan, China
    • Yong Yao, MD · Contact · 13837136563
    Recruiting
  • Tongji Hospital of Tongji Medical College of HUST
    Wuhan, Hubei, China
    • Furong Wang, MD · Contact · 18627126298
    Recruiting
  • Xiangya Hospital Central South University
    Changsha, Hunan, China
    • Fangfang Bi, MD · Contact · 13739064027
    Recruiting
  • The First People'S Hospital of Kunshan
    Kunshan, Jiangsu, China
    • Yan Zhang, MD · Contact · 13962638897
    Recruiting
  • Nanjing Zijin Hospital
    Nanjing, Jiangsu, China
    • Changbao Wang, MD · Contact · 13770722709
    Recruiting
  • Zhongda Hospital Southeast Universtiy
    Nanjing, Jiangsu, China
    • Hui Jiao, MD · Contact · 1581881150
    Recruiting
  • The second Affiliated Hospital of Suzhou University
    Suzhou, Jiangsu, China
    • Weidong Hu, MD · Contact · 1351003701
    Recruiting
  • Yancheng Third People's Hospital
    Yancheng, Jiangsu, China
    • Lijuan Wu, MD · Contact · 13912569779
    Recruiting
  • Ganzhou People'S Hospital
    Ganzhou, Jiangxi, China
    • Chaohui Lai, MD · Contact · 13879729792
    Recruiting
  • The First Hospital of Jilin University
    Changchun, Jilin, China
    • Xin Sun, MD · Contact · 13596116866
    Recruiting
  • Qilu Hospital of Shandong University
    Jinan, Shandong, China
    • Qinzhou Wang, MD · Contact · 18560085523
    Recruiting
  • Affiliated Hospital of Jining Medical Hospital
    Jining, Shandong, China
    • Shaoying Wu, MD · Contact · 18678766806
    Recruiting
  • Linyi People'S Hospital
    Linyi, Shandong, China
    • Guangying Wang, MD · Contact · 13695395899
    Recruiting
  • Qilu Hospital of Shandong University(Qingdao)
    Qingdao, Shandong, China
    • Jijun Teng, MD · Contact · 18661806108
    Recruiting
  • The Affiliated Hospital of Qingdao University
    Qingdao, Shandong, China
    • Cuiping Zhao, MD · Contact · 18561810336
    Recruiting
  • Yantai Yuhuangding Hospital
    Yantai, Shandong, China
    • Hong Liu, MD · Contact · 13964528128
    Recruiting
  • The First Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, Shanxi, China
    • Chen Chen, MD · Contact · 13363954570
    Recruiting
  • Xi'an Encephalopathy of Traditional Chinese Medicine Hospital
    Xi'an, Shanxi, China
    • Bingcan Yan · Contact · 13379236669
    Recruiting
  • Chongqing People's Hospital
    Chongqing, Sichuang, China
    • Chengqun Wang, MD · Contact · 15998950878
    Recruiting
  • Red Cross Hospital of Hangzhou
    Hangzhou, Zhejiang, China
    • Mingming Ma, MD · Contact · 13738132607‬
    Recruiting
  • Zhejiang Province Xiaoshan Hospital
    Hanzhou, Zhejiang, China
    • Kai Fang, MD · Contact · 18967168308
    Recruiting
  • The First People'S Hospital of Jiashan
    Jiaxing, Zhejiang, China
    • Yingshuai Shi, MD · Contact · 18358364799
    Recruiting
  • The First People'S Hospital of Wenling
    Wenling, Zhejiang, China
    • Haibo Cai, MD · Contact · 13905565806
    Recruiting
  • The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
    Wenzhou, Zhejiang, China
    • Beilei Hu · Contact · 15858515599
    Recruiting
  • Wenzhou Hospital of Chinese Medicine
    Wenzhou, Zhejiang, China
    • Ling Chen, MD · Contact · 13868403777
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 12, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05454397
Lead sponsor
Nanfang Hospital, Southern Medical University
Collaborators
First Affiliated Hospital of Fujian Medical University, Yantai Yuhuangding Hospital, The First Hospital of Jilin University, Qilu Hospital of Shandong University, ZHEJIANG PROVINCE XIAOSHAN HOSPITAL, Affiliated Wenling Hospital of Wenzhou Medical University, Ganzhou People's Hospital, Affiliated Hospital of Jining Medical hospital, Henan Provincial People's Hospital, Zhongda Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Kunshan, The 2nd Affiliated Hospital of Wenzhou Medical University, THE FIRST PEOPLE'S HOSPITAL OF JIASHAN, First Affiliated Hospital Xi'an Jiaotong University, Fujian Province Zhangzhou Hospital, People's Hospital of Chongqing, Nanjing Zijin Hospital, Red Cross Hospital, Hangzhou, China, Wenzhou Hospital of Chinese Medicine, Kaifeng Central Hospital, First Affiliated Hospital of Guangxi Medical University, Zhongshan Hospital of Xiamen University, Xi'an Encephalopathy of Traditional Chinese Medicine Hospital, 903 Hospital of the Chinese People's Liberation Army Joint Logistics and Security Forces, Xiangya Hospital of Central South University, Second Affiliated Hospital of Suzhou University, Tongji Hospital, The Affiliated Hospital o fQingdao University, The First Affiliated Hospital of Anhui Medical University, Yancheng Third People's Hospital, Linyi People's Hospital, Dongfang Hospital of Beijing University of Chinese Medicine, The Affiliated Hospital of Qingdao University
Responsible party
Sponsor
First posted
Jul 12, 2022
Start date
Sep 1, 2022 (estimated)
Primary completion
Oct 15, 2022 (estimated)
Completion
Oct 15, 2023 (estimated)
Last update
Jul 12, 2022

Study contacts

JinYu Chen, M.D.
Contact
568344684@qq.com
+8615876578154
Suyue Pan, M.D., Ph.D.
principal investigator · Department of Neurology, Nanfang Hospital, Southern Medical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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