A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Medical College of Wisconsin

Status: Completed

Conditions: Septic Shock

Treatments: Other: Enteral nutrition

Study type: Interventional

Funder types: Other

Identifiers

NCT02025127

19966

Details and patient eligibility

About

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.

Full 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Trophic feeding

Experimental group

Description:

Mechanically ventilated patients with septic shock \> 18 years old randomized to this group will receive more than 50 but less than 600 kilocalories of enteral nutrition per day while on vasopressors. This will be started within 24 hours of intensive care unit admission.

Treatment:

Other: Enteral nutrition

No Enteral Nutrition

No Intervention group

Description:

Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support.