Clinical trial NCT05454397: A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
Official title: A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Stroke
Keywords: Stroke; Dysphagia;Nutrition management；
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: First Affiliated Hospital of Fujian Medical University
name: Yantai Yuhuangding Hospital
name: The First Hospital of Jilin University
name: Qilu Hospital of Shandong University
name: ZHEJIANG PROVINCE XIAOSHAN HOSPITAL
name: Affiliated Wenling Hospital of Wenzhou Medical University
name: Ganzhou People's Hospital
name: Affiliated Hospital of Jining Medical hospital
name: Henan Provincial People's Hospital
name: Zhongda Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: The First People's Hospital of Kunshan
name: The 2nd Affiliated Hospital of Wenzhou Medical University
name: THE FIRST PEOPLE'S HOSPITAL OF JIASHAN
name: First Affiliated Hospital Xi'an Jiaotong University
name: Fujian Province Zhangzhou Hospital
name: People's Hospital of Chongqing
name: Nanjing Zijin Hospital
name: Red Cross Hospital, Hangzhou, China
name: Wenzhou Hospital of Chinese Medicine
name: Kaifeng Central Hospital
name: First Affiliated Hospital of Guangxi Medical University
name: Zhongshan Hospital of Xiamen University
name: Xi'an Encephalopathy of Traditional Chinese Medicine Hospital
name: 903 Hospital of Chinese People's Liberation Army
name: Xiangya Hospital of Central South University
name: Second Affiliated Hospital of Suzhou University
name: Tongji Hospital
name: The Affiliated Hospital o fQingdao University
name: The First Affiliated Hospital of Anhui Medical University
name: Yancheng Third People's Hospital
name: Linyi People's Hospital
name: Dongfang Hospital of Beijing University of Chinese Medicine
name: The Affiliated Hospital of Qingdao University
First posted: 2022-07-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Nutrition implementation rate
timeFrame: The first day of admission； the seventh day of admission； the day before discharge.
measure: Nutrition compliance rate of stroke inpatients
timeFrame: The first day of admission； the seventh day of admission； the day before discharge.
Secondary outcomes:
measure: 30-day post-discharge mortality
timeFrame: 30-day post-discharge
measure: Infection rate
timeFrame: 30-day post-discharge
measure: Readmission rate
timeFrame: 30-day post-discharge
measure: Functional prognosis
timeFrame: 30-day post-discharge
Other outcomes:
Locations:
city: Hefei
country: China
facility: The First Affiliated Hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Dongfang Hospital of Beijing University of Chinese Medicine
state: Beijing
city: Fuzhou
country: China
facility: The First Afilliated Hospital of Fujian Medical University
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen University
state: Fujian
city: Zhengzhou
country: China
facility: Fujian Province Zhangzhou Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Nanning
country: China
facility: The First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Ha'erbin
country: China
facility: The second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Kai Feng
country: China
facility: Kaifeng Central Hospital
state: Henan
city: Zhengzhou
country: China
facility: Henan Provincial People'S Hospital
state: Henan
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of HUST
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Kunshan
country: China
facility: The First People'S Hospital of Kunshan
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Zijin Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Zhongda Hospital Southeast Universtiy
state: Jiangsu
city: Suzhou
country: China
facility: The second Affiliated Hospital of Suzhou University
state: Jiangsu
city: Yancheng
country: China
facility: Yancheng Third People's Hospital
state: Jiangsu
city: Ganzhou
country: China
facility: Ganzhou People'S Hospital
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi People'S Hospital
state: Shandong
city: Qingdao
country: China
facility: Qilu Hospital of Shandong University(Qingdao)
state: Shandong
city: Qingdao
country: China
facility: The Affiliated Hospital of Qingdao University
state: Shandong
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Xi'an
country: China
facility: Xi'an Encephalopathy of Traditional Chinese Medicine Hospital
state: Shanxi
city: Chongqing
country: China
facility: Chongqing People's Hospital
state: Sichuang
city: Hangzhou
country: China
facility: Red Cross Hospital of Hangzhou
state: Zhejiang
city: Hanzhou
country: China
facility: Zhejiang Province Xiaoshan Hospital
state: Zhejiang
city: Jiaxing
country: China
facility: The First People'S Hospital of Jiashan
state: Zhejiang
city: Wenling
country: China
facility: The First People'S Hospital of Wenling
state: Zhejiang
city: Wenzhou
country: China
facility: The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Hospital of Chinese Medicine
state: Zhejiang
Study officials:
affiliation: Department of Neurology, Nanfang Hospital, Southern Medical University
name: Suyue Pan, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: