Septic Shock Clinical Trial
Official title:
A Randomized Controlled Study of Enteral Nutrition in Septic Shock
There is a paucity of data on the timing and role of enteral nutrition in septic shock.
The primary aim of this study is to conduct a phase III single-center pilot randomized
controlled trial comparing early trophic enteral nutrition to 'no enteral nutrition' in
mechanically ventilated septic shock patients to determine feasibility.
Septic shock represents the body's dysregulated response to an infection, manifesting as
persistent hypotension (mean arterial pressure < 70 mmHg) despite intravenous (IV) fluid
resuscitation. Severe sepsis and septic shock are major healthcare problems, affecting
millions of people around the world each year In critically ill patients without shock,
provision of enteral nutrition within 24-48 hours has shown to preserve intestinal
epithelium, maintain brush border enzyme activity, maintenance of barrier function to enhance
immune function, and preservation of tight cell junctions to reduce permeability. These
benefits of enteral nutrition are postulated to prevent downstream complications of
nosocomial infections and the multiple organ dysfunction syndrome (MODS), though direct data
addressing this question are lacking.
The primary aim of this study is to conduct a phase III single-center pilot randomized
controlled trial comparing early trophic EN to 'no EN' in mechanically ventilated septic
shock patients to determine feasibility of achieving >75% consent and compliance rate and
<10% contamination rate.
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