Measurements and Main Results: Patients received the CAM-ICU, Richmond Agitation-Sedation Scale (RASS), and Delirium Rating Scale-Revised (DRS-R)-98 assessments. A 7-point scale (0-7) was derived from responses to the CAM-ICU and RASS items. CAM-ICU-7 showed high internal consistency (Cronbach’s alpha=0.85) and good correlation with DRS-R-98 scores (correlation coefficient=0.64). Known-groups validity was supported by the separation of mechanically ventilated and non-ventilated assessments. Median CAM-ICU-7 scores demonstrated good predictive validity with higher odds (OR=1.47; 95% CI=1.30-1.66) of inhospital mortality, and lower odds (OR=0.8; 95% CI=0.72-0.9) of being discharged home after adjusting for age, race, gender, severity of illness, and chronic comorbidities. Higher CAM-ICU-7 scores were also associated with increased length of ICU stay (p=0.001).
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.