Acute StrokeNCT05454397
A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
An observational study of Acute Stroke, run by Nanfang Hospital, Southern Medical University at 34 sites in China.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Stroke
- How many people
- 2,000 participants
- Where
- 34 sitesChina
- Study dates
- 1 Sep 2022to 15 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Transferred during treatment, contraindications to nutritional therapy (e.g., hemodynamic instability, gastrointestinal bleeding (bleeding >100 ml), other nutritional studies, pregnancy.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
China34 sites, 34 recruiting
- Recruiting
Dongfang Hospital of Beijing University of Chinese Medicine
Beijing, Beijing Municipality
Baoxin Chen, MD, 13581546499
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin
Xin Sun, MD, 13596116866
- Recruiting
Xiangya Hospital Central South University
Changsha, Hunan
Fangfang Bi, MD, 13739064027
- Recruiting
Chongqing People's Hospital
Chongqing, Sichuang
Chengqun Wang, MD, 15998950878
- Recruiting
The First Afilliated Hospital of Fujian Medical University
Fuzhou, Fujian
Zhiqiang Wang, MD, 13805059300
- Recruiting
Ganzhou People'S Hospital
Ganzhou, Jiangxi
Chaohui Lai, MD, 13879729792
- Recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong
JinYu Chen, MD, 568344684@qq.com
Suyue Pan, M.D., Ph.D.
- Recruiting
Red Cross Hospital of Hangzhou
Hangzhou, Zhejiang
Mingming Ma, MD, 13738132607
- Recruiting
Zhejiang Province Xiaoshan Hospital
Hanzhou, Zhejiang
Kai Fang, MD, 18967168308
- Recruiting
The second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Lihua Wang, MD, 13100881600
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui
Yajuan Hu, MD, 13956912105
- Recruiting
The First People'S Hospital of Jiashan
Jiaxing, Zhejiang
Yingshuai Shi, MD, 18358364799
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Qinzhou Wang, MD, 18560085523
- Recruiting
Affiliated Hospital of Jining Medical Hospital
Jining, Shandong
Shaoying Wu, MD, 18678766806
- Recruiting
Kaifeng Central Hospital
Kaifeng, Henan
Yan Zhao, MD, 15137884148
- Recruiting
The First People'S Hospital of Kunshan
Kunshan, Jiangsu
Yan Zhang, MD, 13962638897
- Recruiting
Linyi People'S Hospital
Linyi, Shandong
Guangying Wang, MD, 13695395899
- Recruiting
Nanjing Zijin Hospital
Nanjing, Jiangsu
Changbao Wang, MD, 13770722709
- Recruiting
Zhongda Hospital Southeast Universtiy
Nanjing, Jiangsu
Hui Jiao, MD, 1581881150
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
Zhijian Liang, MD, 13737944579
- Recruiting
Qilu Hospital of Shandong University(Qingdao)
Qingdao, Shandong
Jijun Teng, MD, 18661806108
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong
Cuiping Zhao, MD, 18561810336
- Recruiting
The second Affiliated Hospital of Suzhou University
Suzhou, Jiangsu
Weidong Hu, MD, 1351003701
- Recruiting
The First People'S Hospital of Wenling
Wenling, Zhejiang
Haibo Cai, MD, 13905565806
- Recruiting
The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU
Wenzhou, Zhejiang
Beilei Hu, 15858515599
- Recruiting
Wenzhou Hospital of Chinese Medicine
Wenzhou, Zhejiang
Ling Chen, MD, 13868403777
- Recruiting
Tongji Hospital of Tongji Medical College of HUST
Wuhan, Hubei
Furong Wang, MD, 18627126298
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
Chen Chen, MD, 13363954570
- Recruiting
Xi'an Encephalopathy of Traditional Chinese Medicine Hospital
Xi’an, Shanxi
Bingcan Yan, 13379236669
- Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian
Lihong Su, MD, 18060486879
- Recruiting
Yancheng Third People's Hospital
Yancheng, Jiangsu
Lijuan Wu, MD, 13912569779
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong
Hong Liu, MD, 13964528128
- Recruiting
Fujian Province Zhangzhou Hospital
Zhengzhou, Fujian
Bailing Chen, MD, 15892014859
- Recruiting
Henan Provincial People'S Hospital
Zhengzhou, Henan
Yong Yao, MD, 13837136563
About this study
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.
- Conditions
- Acute Stroke
- Being tested
- Observational study, no intervention
- Keywords
- Stroke; Dysphagia;Nutrition management；
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| case group | Patients with acute stroke with nutritional risk Receives: Other: Observational study, no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutrition implementation rate
Proportion of patients hospitalized for stroke who were given nutritional support
Measured: 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
Measured: The first day of admission； the seventh day of admission； the day before discharge.
Secondary outcomes (4)
30-day post-discharge mortality
Proportion of enrolled patients who died 30 days after discharge from the hospital
Measured: 30-day post-discharge
Infection rate
Proportion of enrolled patients with pulmonary infection 30 days after discharge from hospital.
Measured: 30-day post-discharge
Readmission rate
Proportion of patients enrolled who were readmitted for various reasons 30 days after discharge.
Measured: 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.
Measured: 30-day post-discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2022
- Study start1 Sep 2022 (estimated)
- Primary completion15 Oct 2022 (estimated)
- Study completion15 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute StrokeStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- 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 City People's Hospital, Affiliated Hospital of Jining Medical University, Henan Provincial People's Hospital, Zhongda Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Kunshan, Second Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Jiashan County, 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 Xiamen University, Xi'an Encephalopathy of Traditional Chinese Medicine Hospital, 903 Hospital of Chinese People's Liberation Army, 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 Beijing University of Chinese Medicine, The Affiliated Hospital of Qingdao University
- Responsible party
- Sponsor
- Investigators
- Suyue Pan, M.D., Ph.D., Principal investigator, Department of Neurology, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05454397
- Sponsor's protocol ID
- NFEC-2020-234
- Status last verified
- Oct 2021
- First submitted
- 1 Jul 2022
- Last updated
- 12 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Status of Nutritional Risk Screening and Nutritional Therapy in Neurology Hospitalized Stroke Patients
- ClinicalTrials.gov ID
- NCT05454397
- Acronym / sponsor ID
- NFEC-2020-234
- Conditions
- Acute Stroke
- Keywords
- Stroke; Dysphagia;Nutrition management；
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- 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 City People's Hospital, Affiliated Hospital of Jining Medical University, Henan Provincial People's Hospital, Zhongda Hospital, The Second Affiliated Hospital of Harbin Medical University, The First People's Hospital of Kunshan, Second Affiliated Hospital of Wenzhou Medical University, The First People's Hospital of Jiashan County, 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 Xiamen University, Xi'an Encephalopathy of Traditional Chinese Medicine Hospital, 903 Hospital of Chinese People's Liberation Army, 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 Beijing University of Chinese Medicine, The Affiliated Hospital of Qingdao University
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 15 Oct 2022 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 12 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| case group | – | Other: Observational study, no interventionPatients with acute stroke with nutritional risk |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Transferred during treatment, contraindications to nutritional therapy (e.g., hemodynamic instability, gastrointestinal bleeding (bleeding >100 ml), other nutritional studies, pregnancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | case group |
Primary outcome
Nutrition implementation rate
Time frame: The first day of admission； the seventh day of admission； the day before discharge.
Proportion of patients hospitalized for stroke who were given nutritional support
Nutrition compliance rate of stroke inpatients
Time frame: The first day of admission； the seventh day of admission； the day before discharge.
Percentage of patients hospitalized for stroke whose nutritional indicators and nutritional status met the guidelines after being given nutritional support
4 secondary outcomes
30-day post-discharge mortality
Time frame: 30-day post-discharge
Infection rate
Time frame: 30-day post-discharge
Readmission rate
Time frame: 30-day post-discharge
Functional prognosis
Time frame: 30-day post-discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suyue Pan, M.D., Ph.D. principal investigator
Department of Neurology, Nanfang Hospital, Southern Medical University
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Stroke, run by Nanfang Hospital, Southern Medical University at 34 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact JinYu Chen, M.D. (+8615876578154, 568344684@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nutrition implementation rate (time frame: The first day of admission； the seventh day of admission； the day before discharge.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2022.