A Randomized Controlled of Enteral Nutrition in Septic Shock

A Randomized Controlled of Enteral Nutrition in Septic Shock

Full Study Title: A Randomized Controlled of Enteral Nutrition in Septic Shock

Summary

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.

There is a paucity of data on the timing and role of enteral nutrition in septic shock.

Specific aim 1: To examine the effect of enteral nutrition of >50 kcal/day but <600 kcal/day compared to no enteral nutrition initiated with 24 hours of admission on the number of intensive care unit free days’ in patients with septic shock.

Hypothesis 1: The investigators hypothesize that amongst mechanically ventilated patients with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day but <600 kcal/day, as compared to no enteral nutrition, improves the primary outcome of number of intensive care unit free days’.

Specific aim 2: To examine the effect of enteral nutrition of >50 kcal/day but< 600 kcal/day initiated with 24 hours of admission on in-hospital mortality, mechanical ventilator free days, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy in patients with septic shock.

Hypothesis 2: The investigators hypothesize that amongst mechanically ventilated patients with a diagnosis of septic shock, the initiation of early enteral nutrition of >50 kcal/day but <600 kcal/day, as compared to no enteral nutrition, decreases mortality, duration of mechanical ventilation, time to 50% reduction in vasopressor dose, and time to initiation of physical therapy.

Participant Eligibility

Inclusion Criteria:

  • Adults greater than or equal to 18 years old
  • Clinical diagnosis of septic shock
  • Mechanically ventilation anticipated for at least 48 hours

Exclusion Criteria:

  • Do not resuscitate order
  • Not able to obtain consent
  • Those not able to be randomized within 18 hours
  • Those with small bowel ischemia or obstruction
  • Protracted ileus, intractable vomiting, major gastrointestinal bleeding defined as needing 2 or more units of packed red cells, and any bowel surgery within the previous 30 days prior to intensive care unit admission
  • Those with a contraindication for placement of a feeding tube

Study ID: NCT02025127

Study Sites
Medical College of Wisconsin/Froedtert Hospital

Principal Investigator(s)
Jayshil J Patel, MD

Contact
Jeanette Graf
414-955-7042
jgraf@mcw.edu