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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Stroke
• Intervention / Treatment: Other: Observational study, no intervention

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.

• Study Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: JinYu Chen, M.D.; Phone Number: +8615876578154; Email: 568344684@qq.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
case group; Patients with acute stroke with nutritional risk	Other: Observational study, no intervention; Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nutrition implementation rate	Proportion of patients hospitalized for stroke who were given nutritional support	The first day of admission； the seventh day of admission； the day before discharge.
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	The first day of admission； the seventh day of admission； the day before discharge.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
30-day post-discharge mortality	Proportion of enrolled patients who died 30 days after discharge from the hospital	30-day post-discharge
Infection rate	Proportion of enrolled patients with pulmonary infection 30 days after discharge from hospital.	30-day post-discharge
Readmission rate	Proportion of patients enrolled who were readmitted for various reasons 30 days after discharge.	30-day post-discharge
Functional prognosis	Functional prognosis of the enrolled patients, such as life skills, motor and sensory functions, cognitive functions and swallowing functions.	30-day post-discharge

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: The First Affiliated Hospital of Anhui Medical University; Xiangya Hospital of Central South University; Tongji Hospital; Qilu Hospital of Shandong University; First Affiliated Hospital of Fujian Medical University; The Affiliated Hospital of Qingdao University; The First Hospital of Jilin University; Henan Provincial People's Hospital; Zhongda Hospital; Red Cross Hospital, Hangzhou, China; The Second Affiliated Hospital of Harbin Medical University; Yantai Yuhuangding Hospital; Second Affiliated Hospital of Suzhou University; First Affiliated Hospital of Guangxi Medical University; Linyi People's Hospital; The First People's Hospital of Wenling; Kaifeng Central Hospital; People's Hospital of Chongqing; Yancheng Third People's Hospital; The First People's Hospital of Kunshan; ZHEJIANG PROVINCE XIAOSHAN HOSPITAL; Ganzhou People's Hospital; Affiliated Hospital of Jining Medical hospital; The 2nd Affiliated Hospital of Wenzhou Medical University; THE FIRST PEOPLE'S HOSPITAL OF JIASHAN; The First Affiliated Hospital of Xi'an Jiaotong University Medical College; Fujian Province Zhangzhou Hospital; Nanjing Zijin Hospital; Wenzhou Hospital of Chinese Medicine; 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; The Affiliated Hospital o fQingdao University; Dongfang Hospital of Beijing University of Chinese Medicine
• Investigators: Principal Investigator: Suyue Pan, M.D., Ph.D., Department of Neurology, Nanfang Hospital, Southern Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 15, 2022
• Study Completion (Anticipated): October 15, 2023

Study Registration Dates

• First Submitted: July 1, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 12, 2022

Study Record Updates

• Last Update Posted (Actual): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Stroke; Dysphagia;Nutrition management；
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: NFEC-2020-234

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No