Trophic Enteral Feeding Combined With Supplemental Parenteral Nutrition Treatment in Patients With Severe Stroke (OPENS-2): a Multicentre, Prospective, Randomised, Open-label, Blinded-endpoint Trial

Status: Recruiting
Location: See all (30) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age≥18 years

• Definite diagnosis of acute stroke (GCS ≤12 or NIHSS≥11)

• The randomized nutritional treatment could be initiated up to 72 hours after symptom onset.

• Any cases of profiles #3 through 5 in Water Swallowing Test or with disorder of consciousness.

• Plan to receive nutritional support treatment for at least 7 days.

• Informed consent.

Locations
Other Locations
China
The First Hospital of Changsha City
NOT_YET_RECRUITING
Changsha
Chongqing University Three Gorges Hospital
RECRUITING
Chongqing
Daping Hospital, The Third Military Medical University
RECRUITING
Chongqing
Nanfang Hospital, Southern Medical University
NOT_YET_RECRUITING
Guangzhou
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
RECRUITING
Guangzhou
The Affiliated Hospital of Guizhou Medical University
RECRUITING
Guiyang
Qilu Hospital of Shangdong University
NOT_YET_RECRUITING
Jinan
The PLA 960 Hospital
RECRUITING
Jinan
The Second Hospital of Shandong University
RECRUITING
Jinan
Gansu Provincal Central Hospital
RECRUITING
Lanzhou
Liaocheng People's Hospital
RECRUITING
Liaocheng
The Second Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
People's Hospital of Xinjiang Uygur Autonomous Region
RECRUITING
Ürümqi
The Second Affiliated Hospital of Xinjiang Medical University
RECRUITING
Ürümqi
Tongji Hospital
RECRUITING
Wuhan
Department of Neurology, Xijing Hospital
RECRUITING
Xi'an
Shaanxi Second Provincal People's Hospital
RECRUITING
Xi'an
Shannxi Provincal People's Hospital
NOT_YET_RECRUITING
Xi'an
Tangdu Hospital
NOT_YET_RECRUITING
Xi'an
The first affiliated hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The First Affiliated Hospital of Xi'an Medical University
RECRUITING
Xi'an
Xi'an Central Hospital
NOT_YET_RECRUITING
Xi'an
Xi'an Gaoxin Hospital
RECRUITING
Xi'an
Xi'an No.3 Hospital
RECRUITING
Xi'an
The First People's Hospital of Xianyang
RECRUITING
Xianyang
Xianyang Hospital, Yan'an University
RECRUITING
Xianyang
General Hospital of Ningxia Medical University
RECRUITING
Yinchuan
Yulin No.1 Hospital
NOT_YET_RECRUITING
Yulin
Yulin No.2 Hospital
NOT_YET_RECRUITING
Yulin
First Affiliated Hospital of Zhengzhou University
RECRUITING
Zhengzhou
Contact Information
Primary
Wen Jiang, Ph.D
jiangwen@fmmu.edu.cn
86-029-84771319
Backup
Xuan Wang, MD
786369892@qq.com
86-029-84773664
Time Frame
Start Date: 2023-12-20
Estimated Completion Date: 2026-10-31
Participants
Target number of participants: 546
Treatments
Active_comparator: Full enteral feeding
Patients will receive full enteral feeding through nasogastric tube or nasointestinal tube.
Experimental: Trophic enteral feeding combined with supplemental parenteral nutrition
Patients will receive trophic enteral feeding combined with supplemental parenteral feeding.
Related Therapeutic Areas
Sponsors
Collaborators: The Second Hospital of Shandong University, First Affiliated Hospital Xi'an Jiaotong University, Yulin No.2 Hospital, Shaanxi Provincial People's Hospital, Xi'an Central Hospital, Xijing Hospital, Gansu Provincial Central Hospital, Qilu Hospital of Shandong University, First Hospital Affiliated to Zhengzhou University, Nanfang Hospital, Southern Medical University, First People's Hospital of Xianyang, PLA 960 Hospital, Daping Hospital, The Third Military Medical University (Army Medical University), The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Tang-Du Hospital, Xi'an Gaoxin Hospital, Tongji Hospital, Yulin No.1 Hospital, Xi'an No.3 Hospital, The First Hospital of Changsha City
Leads: Wen Jiang-3

This content was sourced from clinicaltrials.gov