Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT05998902

Optimizing Early Nutrition Support in Severe Stroke-2

Led by Wen Jiang-3 · Updated on 2026-03-19

546

Participants Needed

30

Research Sites

149 weeks

Total Duration

On this page

Sponsors

W

Wen Jiang-3

Lead Sponsor

T

Tang-Du Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

Post stroke pneumonia (PSP) is one of the common early complications of stroke. Post-stroke infections, in general, are associated with less favorable neurologic outcomes. Aspiration is one of the most feared complications of enteral nutrition and can lead to the occurrence of pneumonia. Severe stroke patients are at high risk for aspiration due to some factors such as the reduced level of consciousness, inability to protect the airway and so on. The purpose of this study is to explore the ideal nutrition support strategy for patient with acute severe stroke to help reduce the incidence of PSP and improve the prognosis.

CONDITIONS

Official Title

Optimizing Early Nutrition Support in Severe Stroke-2

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Definite diagnosis of acute stroke with Glasgow Coma Scale (GCS) score of 12 or less or National Institutes of Health Stroke Scale (NIHSS) score of 11 or higher
  • Nutritional treatment can be started within 72 hours after stroke symptom onset
  • Water Swallowing Test results showing profiles #3 through 5 or presence of disorder of consciousness
  • Plan to receive nutritional support treatment for at least 7 days
  • Provided informed consent to participate
Not Eligible

You will not qualify if you...

  • Currently receiving parenteral nutrition support
  • Have contraindications to enteral nutrition
  • Have a disease with life expectancy less than 7 days
  • Admission with signs of infection
  • Dementia or severe disability (modified Rankin Scale over 4) before stroke
  • Used antibiotics within the previous 7 days
  • Diagnosis of subarachnoid hemorrhage or cerebral arteriovenous malformation
  • Presence of advanced cancer, severe pulmonary dysfunction (FEV1 less than 50% or moderate to severe acute lung injury), cardiac insufficiency (NYHA class greater than I, EF less than 50%, or significant cardiac abnormalities), severe liver failure (Child-Pugh score 7 or higher), or severe renal failure (glomerular filtration rate 30 mL/min or less or serum creatinine 4 mg/dL or higher)
  • Currently participating in another clinical trial
  • Pregnant woman
  • Considered highly likely not to follow study treatment or follow-up protocol

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 30 locations

1

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China, 404100

Actively Recruiting

2

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Actively Recruiting

3

Gansu Provincal Central Hospital

Lanzhou, Gansu, China

Actively Recruiting

4

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Not Yet Recruiting

5

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Actively Recruiting

6

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China, 550000

Actively Recruiting

7

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Actively Recruiting

8

Tongji Hospital

Wuhan, Hubei, China

Actively Recruiting

9

The First Hospital of Changsha City

Changsha, Hunan, China

Not Yet Recruiting

10

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330000

Actively Recruiting

11

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China, 750000

Actively Recruiting

12

Shaanxi Second Provincal People's Hospital

Xi'an, Shaanxi, China, 710000

Actively Recruiting

13

Tangdu Hospital

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

14

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710000

Actively Recruiting

15

Xi'an Central Hospital

Xi'an, Shaanxi, China, 710000

Not Yet Recruiting

16

Department of Neurology, Xijing Hospital

Xi'an, Shaanxi, China

Actively Recruiting

17

Shannxi Provincal People's Hospital

Xi'an, Shaanxi, China

Not Yet Recruiting

18

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

Actively Recruiting

19

Xi'an Gaoxin Hospital

Xi'an, Shaanxi, China

Actively Recruiting

20

Xi'an No.3 Hospital

Xi'an, Shaanxi, China

Actively Recruiting

21

Xianyang Hospital, Yan'an University

Xianyang, Shaanxi, China, 712000

Actively Recruiting

22

The First People's Hospital of Xianyang

Xianyang, Shaanxi, China

Actively Recruiting

23

Yulin No.1 Hospital

Yulin, Shaanxi, China

Not Yet Recruiting

24

Yulin No.2 Hospital

Yulin, Shaanxi, China

Not Yet Recruiting

25

Qilu Hospital of Shangdong University

Jinan, Shandong, China

Not Yet Recruiting

26

The PLA 960 Hospital

Jinan, Shandong, China

Actively Recruiting

27

The Second Hospital of Shandong University

Jinan, Shandong, China

Actively Recruiting

28

Liaocheng People's Hospital

Liaocheng, Shandong, China, 252000

Actively Recruiting

29

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China, 830000

Actively Recruiting

30

The Second Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China, 830000

Actively Recruiting

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Research Team

W

Wen Jiang, Ph.D

CONTACT

X

Xuan Wang, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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