Optimizing early enteral nutrition in severe stroke (OPENS): protocol for a multicentre randomized controlled trial

Area of Science:

• Neurology
• Critical Care Medicine
• Clinical Nutrition

Background:

• Malnutrition significantly impacts prognosis in critically ill patients.
• Evidence is lacking on initial enteral feeding strategies for severe stroke.
• Early nutrition management is vital for severe stroke patient recovery.

Purpose of the Study:

• To compare modified full enteral nutrition (EN) with permissive underfeeding in severe stroke patients.
• To determine the optimal initial feeding strategy for severe stroke.
• To bridge the evidence gap in enteral nutrition for acute severe stroke.

Main Methods:

• Multicenter randomized controlled trial (OPENS trial).
• 600 adult patients with severe stroke randomized into three groups: standard full EN, modified full EN, or permissive underfeeding.
• Primary outcome: poor outcome (modified Rankin Scale ≥3) at 90 days.

Main Results:

• Primary outcome: proportion of participants with a poor outcome at day 90.
• Secondary outcomes: complication rates, disability at discharge, activities of daily living at day 90.
• Analysis using multivariate logistic regression adjusted for covariates.

Conclusions:

• The OPENS trial investigates the best initial feeding strategy for acute severe stroke.
• Findings will inform clinical practice regarding enteral nutrition in severe stroke.
• This study addresses a critical gap in managing severe stroke patients.