Optimizing Early Nutrition Support in Severe Stroke-2
NCT05998902 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 546
Last updated 2026-03-19
Summary
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
- Severe Stroke
- Acute Stroke
- Dysphagia
Interventions
- PROCEDURE
-
Trophic enteral feeding combined with supplemental parenteral nutrition
The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Patients will receive the trophic enteral feeding with a caloric target of 500kcal/d (20-35ml/h), and the remaining calories are supplemented by parenteral nutrition. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day.
- PROCEDURE
-
Full enteral feeding
The caloric goal of the first day is one-third of caloric requirements, the second day is half of caloric requirements, the third day is 70-100% and sustained for 1 week. Protein requirements are calculated at 1.2 to 1.5 g per kilogram of body weight per day. Enteral nutrition is given through nasogastric tube or nasointestinal tube.
Sponsors & Collaborators
-
Tang-Du Hospital
collaborator OTHER -
Xi'an Central Hospital
collaborator OTHER -
Xi'an Gaoxin Hospital
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
collaborator OTHER -
Xi'an No.3 Hospital
collaborator OTHER_GOV -
First People's Hospital of Xianyang
collaborator OTHER -
Nanfang Hospital, Southern Medical University
collaborator OTHER -
Tongji Hospital
collaborator OTHER -
Qilu Hospital of Shandong University
collaborator OTHER -
The Second Hospital of Shandong University
collaborator OTHER -
PLA 960 Hospital
collaborator UNKNOWN -
Daping Hospital, The Third Military Medical University (Army Medical University)
collaborator UNKNOWN -
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
collaborator UNKNOWN -
First Hospital Affiliated to Zhengzhou University
collaborator UNKNOWN -
Gansu Provincial Central Hospital
collaborator UNKNOWN -
The First Hospital of Changsha City
collaborator UNKNOWN -
Shaanxi Provincial People's Hospital
collaborator OTHER -
Yulin No.2 Hospital
collaborator OTHER -
Yulin No.1 Hospital
collaborator UNKNOWN -
Xijing Hospital
collaborator OTHER -
Wen Jiang-3
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-12-20
- Primary Completion
- 2026-07-31
- Completion
- 2026-10-31
Countries
- China
Study Locations
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