A Randomized Controlled Study of Enteral Nutrition in Septic Shock



Status:Completed
Conditions:Hospital, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:12/23/2018
Start Date:January 2014
End Date:January 2018

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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.

See above

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
We found this trial at
1
site
Milwaukee, Wisconsin 53226
Principal Investigator: Jayshil J Patel, MD
Phone: 414-955-7040
630
mi
from
Milwaukee, WI
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