NCT02982668

Optimizing Early Enteral Nutrition in Severe Stroke

A Multi-center Randomised Controlled Trial to Explore the Ideal Initial Enteral Feeding Strategies in Patients With Severe Stroke at Acute Stage

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 306 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this academic lead study is to explore the ideal nutritional support strategy for patient with acute severe stroke.

Detailed description

Of high mortality and morbidity, severe stroke is associated with devastating damages in neurologic, respiratory, circulatory and many other systems. The outcomes of patients with severe stroke depend largely on medical strategies on acute stage, especially on nutritional support management. Unfortunately, clinical evidence are sparse and the ideal initial feeding strategy remains disputable. The IF-STROKE study aims to provide reliable data on the effects of modified full enteral feeding (target recruitment 200) and permissive underfeeding in patients with acute severe stroke (target recruitment 200) compared to full enteral feeding (target recruitment 200). Patients presenting with acute (\<72h) severe stroke (GCS ≦ 12 or NIHSS ≧ 11) and dysphagia (defined by Water Swallowing Test) will be randomly assigned to full enteral feeding, modified full enteral feeding, or permissive underfeeding treatment for 7 days.

Conditions

• Severe Stroke
• Acute Stroke
• Dysphagia

Interventions

Type	Name	Description
OTHER	Initial enteral feeding
DRUG	metoclopramide or mosapride	gastrointestinal (GI) motility improving

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2016-12-05
• Last updated: 2021-11-04

Locations

4 sites across 1 country: China