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

Acute Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05454397
• Other study ID #: NFEC-2020-234
• Status: Recruiting
• Start date: September 1, 2022
• Est. completion date: October 15, 2023

Study information

• Verified date: October 2021
• Source: Nanfang Hospital of Southern Medical University
• Contact: JinYu Chen, M.D.
• Phone: +8615876578154
• Email: 568344684[@]qq.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: October 15, 2023
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Stroke
• Stroke

Intervention

Other:
• Observational study, no intervention
Observational study, no intervention

Locations

Country	Name	City	State
China	Dongfang Hospital of Beijing University of Chinese Medicine	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Xiangya Hospital Central South University	Changsha	Hunan
China	Chongqing People's Hospital	Chongqing	Sichuang
China	The First Afilliated Hospital of Fujian Medical University	Fuzhou	Fujian
China	Ganzhou People'S Hospital	Ganzhou	Jiangxi
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The second Affiliated Hospital of Harbin Medical University	Ha'erbin	Heilongjiang
China	Red Cross Hospital of Hangzhou	Hangzhou	Zhejiang
China	Zhejiang Province Xiaoshan Hospital	Hanzhou	Zhejiang
China	The First Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The First People'S Hospital of Jiashan	Jiaxing	Zhejiang
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Affiliated Hospital of Jining Medical Hospital	Jining	Shandong
China	Kaifeng Central Hospital	Kai Feng	Henan
China	The First People'S Hospital of Kunshan	Kunshan	Jiangsu
China	Linyi People'S Hospital	Linyi	Shandong
China	Nanjing Zijin Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast Universtiy	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	Qilu Hospital of Shandong University(Qingdao)	Qingdao	Shandong
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	The second Affiliated Hospital of Suzhou University	Suzhou	Jiangsu
China	The First People'S Hospital of Wenling	Wenling	Zhejiang
China	The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU	Wenzhou	Zhejiang
China	Wenzhou Hospital of Chinese Medicine	Wenzhou	Zhejiang
China	Tongji Hospital of Tongji Medical College of HUST	Wuhan	Hubei
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi
China	Xi'an Encephalopathy of Traditional Chinese Medicine Hospital	Xi'an	Shanxi
China	Zhongshan Hospital Xiamen University	Xiamen	Fujian
China	Yancheng Third People's Hospital	Yancheng	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	Fujian Province Zhangzhou Hospital	Zhengzhou	Fujian
China	Henan Provincial People'S Hospital	Zhengzhou	Henan

Sponsors (35)

Lead Sponsor

Collaborator

Nanfang Hospital of Southern Medical University

903 Hospital of the Chinese People's Liberation Army Joint Logistics and Security Forces, Affiliated Hospital of Jining Medical hospital, Affiliated Hospital of Qingdao University, Dongfang Hospital of Beijing University of Chinese Medicine, First Affiliated Hospital of Fujian Medical University, First Affiliated Hospital of Guangxi Medical University, Fujian Province Zhangzhou Hospital, Ganzhou People's Hospital, Hangzhou Red Cross Hospital, Henan Provincial People's Hospital, Kaifeng Central Hospital, Linyi People's Hospital, Nanjing Zijin Hospital, People's Hospital of Chongqing, Qilu Hospital of Shandong University, Second Affiliated Hospital of Suzhou University, The 2nd Affiliated Hospital of Wenzhou Medical University, The Affiliated Hospital o fQingdao University, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of Xi'an Jiaotong University Medical College, The First Hospital of Jilin University, THE FIRST PEOPLE'S HOSPITAL OF JIASHAN, The First people's Hospital of Kunshan, The First People's Hospital of Wenling, The Second Affiliated Hospital of Harbin Medical University, Tongji Hospital, Wenzhou Hospital of Chinese Medicine, Xi'an Encephalopathy of Traditional Chinese Medicine Hospital, Xiangya Hospital of Central South University, Yancheng Third People's Hospital, Yantai Yuhuangding Hospital, ZHEJIANG PROVINCE XIAOSHAN HOSPITAL, Zhongda Hospital Southeast University, Zhongshan Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	30-day post-discharge mortality	Proportion of enrolled patients who died 30 days after discharge from the hospital	30-day post-discharge
Secondary	Infection rate	Proportion of enrolled patients with pulmonary infection 30 days after discharge from hospital.	30-day post-discharge
Secondary	Readmission rate	Proportion of patients enrolled who were readmitted for various reasons 30 days after discharge.	30-day post-discharge
Secondary	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