A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Study Overview
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Brief Summary
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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
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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. 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.

Official Title
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A Randomized Controlled Study of Enteral Nutrition in Septic Shock

Conditions
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Septic Shock

Intervention / Treatment
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* Other: Enteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trophic feeding<br>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. | Other: Enteral nutrition<br>* Enteral nutrition introduced via a feeding tube<br>|
| No Intervention: No Enteral Nutrition<br>Mechanically ventilated patients with septic shock randomized to this group will receive no enteral nutrition while on vasopressor support. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients consenting to study and remaining compliant with assigned study arm | consent and compliance rate of >75% and contamination rate <10% | 46 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilator free days | Number of days alive and off mechanical ventilatory support out of 30 | 30 days | 
| Hospital mortality | number of patients who died during hospitalization | 30 days | 
| intensive care unit free days | number of days alive and out of the intensive care unit out of 30 | 30 days | 
| change in 48 hour sequential organ failure assessment score, with higher score representing worse outcome | absolute change in sequential organ failure assessment score (range 0-24 points) from day 0 to 48 hours, with higher scores representing worse outcomes | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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septic shock, mechanical ventilation, enteral nutrition, trophic feeding