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

Autor: Patel JJ; Division of Pulmonary and Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Kozeniecki M; Department of Nutrition Services, Froedtert Hospital, Milwaukee, Wisconsin, USA., Peppard WJ; Department of Pharmacy, Froedtert & the Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Peppard SR; Division of Trauma and Critical Care, Department of Surgery, Medical College of Wisconsin, Milwaukee, Wisconsin, USA.; Concordia University Wisconsin School of Pharmacy, Mequon, Wisconsin, USA., Zellner-Jones S; Department of Medicine, Division of Pulmonary & Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Graf J; Department of Medicine, Division of Pulmonary & Critical Care Medicine, Medical College of Wisconsin, Milwaukee, Wisconsin, USA., Szabo A; Institute for Health & Policy, Milwaukee, Wisconsin, USA., Heyland DK; Clinical Evaluation Research Unit, Department of Public Health Sciences, Queen's University, Department of Critical Care Medicine, Kingston General Hospital, Kingston, Ontario, Canada.
Jazyk: angličtina
Zdroj: JPEN. Journal of parenteral and enteral nutrition [JPEN J Parenter Enteral Nutr] 2020 Jul; Vol. 44 (5), pp. 866-873. Date of Electronic Publication: 2019 Sep 19.
DOI: 10.1002/jpen.1706
Abstrakt: 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.
(© 2019 American Society for Parenteral and Enteral Nutrition.)
Databáze: MEDLINE
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