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Phase 3 Pilot Randomized Controlled Trial Comparing Early Trophic Enteral Nutrition With "No Enteral Nutrition" in Mechanically Ventilated Patients With Septic Shock. JPEN J Parenter Enteral Nutr 2020 Jul;44(5):866-873



Pubmed ID




Scopus ID

2-s2.0-85073992718   2 Citations


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.

Author List

Patel JJ, Kozeniecki M, Peppard WJ, Peppard SR, Zellner-Jones S, Graf J, Szabo A, Heyland DK


William J. Peppard PharmD Trauma/Surgical Critical Care Pharmacist in the Pharmacy department at Froedtert Hospital
Aniko Szabo PhD Professor in the Institute for Health and Equity department at Medical College of Wisconsin

jenkins-FCD Prod-482 91ad8a360b6da540234915ea01ff80e38bfdb40a