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

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.