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RECRUITING
NCT05998902
PHASE3

Optimizing Early Nutrition Support in Severe Stroke-2

Sponsor: Wen Jiang-3

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

546

Start Date

2023-12-20

Completion Date

2026-10-31

Last Updated

2026-03-19

Healthy Volunteers

No

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.

Locations (30)

Chongqing University Three Gorges Hospital

Chongqing, Chongqing Municipality, China

Daping Hospital, The Third Military Medical University

Chongqing, Chongqing Municipality, China

Gansu Provincal Central Hospital

Lanzhou, Gansu, China

Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

The Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Tongji Hospital

Wuhan, Hubei, China

The First Hospital of Changsha City

Changsha, Hunan, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

General Hospital of Ningxia Medical University

Yinchuan, Ningxia, China

Shaanxi Second Provincal People's Hospital

Xi'an, Shaanxi, China

Tangdu Hospital

Xi'an, Shaanxi, China

The first affiliated hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Xi'an Central Hospital

Xi'an, Shaanxi, China

Department of Neurology, Xijing Hospital

Xi'an, Shaanxi, China

Shannxi Provincal People's Hospital

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Medical University

Xi'an, Shaanxi, China

Xi'an Gaoxin Hospital

Xi'an, Shaanxi, China

Xi'an No.3 Hospital

Xi'an, Shaanxi, China

Xianyang Hospital, Yan'an University

Xianyang, Shaanxi, China

The First People's Hospital of Xianyang

Xianyang, Shaanxi, China

Yulin No.1 Hospital

Yulin, Shaanxi, China

Yulin No.2 Hospital

Yulin, Shaanxi, China

Qilu Hospital of Shangdong University

Jinan, Shandong, China

The PLA 960 Hospital

Jinan, Shandong, China

The Second Hospital of Shandong University

Jinan, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

People's Hospital of Xinjiang Uygur Autonomous Region

Ürümqi, Xinjiang, China

The Second Affiliated Hospital of Xinjiang Medical University

Ürümqi, Xinjiang, China