NCT02025127

A Randomized Controlled Study of Enteral Nutrition in Septic Shock

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
OTHER	Enteral nutrition	Enteral nutrition introduced via a feeding tube

Timeline

• Start date: 2014-01-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2013-12-31
• Last updated: 2019-08-16

Locations

1 site across 1 country: United States