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Clinical Trial
. 2020 Jul;44(5):866-873.
doi: 10.1002/jpen.1706. Epub 2019 Sep 19.

Phase 3 Pilot Randomized Controlled Trial Comparing Early Trophic Enteral Nutrition With "No Enteral Nutrition" in Mechanically Ventilated Patients With Septic Shock

Jayshil J Patel  1 , Michelle Kozeniecki  2 , William J Peppard  3 , Sarah R Peppard  4   5 , Stephanie Zellner-Jones  6 , Jeanette Graf  6 , Aniko Szabo  7 , Daren K Heyland  8
Affiliations
Clinical Trial

Phase 3 Pilot Randomized Controlled Trial Comparing Early Trophic Enteral Nutrition With "No Enteral Nutrition" in Mechanically Ventilated Patients With Septic Shock

Jayshil J Patel et al. JPEN J Parenter Enteral Nutr. 2020 Jul.

Abstract

Background: The optimal dose and timing of enteral nutrition (EN) in septic shock are unclear.

Methods: We conducted a phase 3 single-center randomized controlled pilot trial comparing early trophic EN with "no EN" in mechanically ventilated adults with septic shock, with the hypothesis that implementing a protocol comparing early trophic EN with "no EN" in patients with septic shock would be feasible. Patients were randomized to early trophic EN or "no EN" until off vasopressor for 3 hours. The primary outcome was feasibility in achieving >75% consent and compliance rate and <10% contamination rate.

Results: One hundred thirty-one patients were eligible for enrollment, and 49 were available for consent. Thirty-one (86%) consented and were randomized and 100% of patients in the early EN arm and 94% in the "no EN" arm completed their protocols. While on vasopressors, early EN group received median 384 kcal, and the "no EN" group received median 0 kcal. Contamination rate was 0 in the early trophic EN arm and 6% in the "no EN" arm. The early EN group had median 25 intensive care unit-free days, as compared with 12 in the "no EN" arm (P = .014). The early EN arm had median 27 ventilator-free days, compared with 14 in "no EN" arm (P = .009).

Conclusion: Our protocol comparing early trophic EN with "no EN" in septic shock was feasible. Early trophic EN may be beneficial, but a larger multicenter trial is warranted to confirm the observed clinical benefits seen in this trial.

Keywords: enteral nutrition; mechanical ventilation; septic shock; trophic nutrition; vasopressor.

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References

    1. Mizock BA. The multiple organ dysfunction syndrome. Dis Mon. 2009;55(8):476-526.
    1. Alverdy JC, Krezalek MA. Collapse of the microbiome, emergence of the pathobiome, and the immunopathology of sepsis. Crit Care Med. 2017;45(2):337-347.
    1. Krezalek MA, DeFazio J, Zaborina O, Zaborin A, Alverdy JC. The shift of an intestinal “microbiome” to a “pathobiome” governs the course and outcome of sepsis following surgical injury. Shock. 2016;45(5):475-482.
    1. Arabi YM, McClave SA. Enteral nutrition should not be given to patients on vasopressor agents. Crit Care Med. 2019;47(9):p e795.
    1. McClave SA, Chang WK. Feeding the hypotensive patient: does enteral feeding precipitate or protect against ischemic bowel? Nutr Clin Pract. 2003;18(4):279-284.

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