NCT05454397

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

34 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 12, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
Last Updated

July 12, 2022

Status Verified

October 1, 2021

Enrollment Period

1 month

First QC Date

July 1, 2022

Last Update Submit

July 7, 2022

Conditions

Keywords

Stroke; Dysphagia;Nutrition management;

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 30-day post-discharge mortality

    30-day post-discharge

  • Infection rate

    30-day post-discharge

  • Readmission rate

    30-day post-discharge

  • Functional prognosis

    30-day post-discharge

Study Arms (1)

case group

Patients with acute stroke with nutritional risk

Other: Observational study, no intervention

Interventions

Observational study, no intervention

case group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

RECRUITING

Dongfang Hospital of Beijing University of Chinese Medicine

Beijing, Beijing Municipality, China

RECRUITING

The First Afilliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

RECRUITING

Zhongshan Hospital Xiamen University

Xiamen, Fujian, China

RECRUITING

Fujian Province Zhangzhou Hospital

Zhengzhou, Fujian, China

RECRUITING

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

RECRUITING

The second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, China

RECRUITING

Kaifeng Central Hospital

Kaifeng, Henan, China

RECRUITING

Henan Provincial People'S Hospital

Zhengzhou, Henan, China

RECRUITING

Tongji Hospital of Tongji Medical College of HUST

Wuhan, Hubei, China

RECRUITING

Xiangya Hospital Central South University

Changsha, Hunan, China

RECRUITING

The First People'S Hospital of Kunshan

Kunshan, Jiangsu, China

RECRUITING

Nanjing Zijin Hospital

Nanjing, Jiangsu, China

RECRUITING

Zhongda Hospital Southeast Universtiy

Nanjing, Jiangsu, China

RECRUITING

The second Affiliated Hospital of Suzhou University

Suzhou, Jiangsu, China

RECRUITING

Yancheng Third People's Hospital

Yancheng, Jiangsu, China

RECRUITING

Ganzhou People'S Hospital

Ganzhou, Jiangxi, China

RECRUITING

The First Hospital of Jilin University

Changchun, Jilin, China

RECRUITING

Qilu Hospital of Shandong University

Jinan, Shandong, China

RECRUITING

Affiliated Hospital of Jining Medical Hospital

Jining, Shandong, China

RECRUITING

Linyi People'S Hospital

Linyi, Shandong, China

RECRUITING

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

RECRUITING

Xi'an Encephalopathy of Traditional Chinese Medicine Hospital

Xi’an, Shanxi, China

RECRUITING

Chongqing People's Hospital

Chongqing, Sichuang, China

RECRUITING

Red Cross Hospital of Hangzhou

Hangzhou, Zhejiang, China

RECRUITING

Zhejiang Province Xiaoshan Hospital

Hanzhou, Zhejiang, China

RECRUITING

The First People'S Hospital of Jiashan

Jiaxing, Zhejiang, China

RECRUITING

The First People'S Hospital of Wenling

Wenling, Zhejiang, China

RECRUITING

The 2nd Affiliated Hospital and Yuying Children's Hospital of WMU

Wenzhou, Zhejiang, China

RECRUITING

Wenzhou Hospital of Chinese Medicine

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Stroke

Interventions

Observation

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Suyue Pan, M.D., Ph.D.

    Department of Neurology, Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

JinYu Chen, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 12, 2022

Study Start

September 1, 2022

Primary Completion

October 15, 2022

Study Completion

October 15, 2023

Last Updated

July 12, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations