6/29/23, 11:42 PM SHOCKEM-Blue Pathway Feedback Search Clinical Topics Home Studies SHOCKEM Blue SHOCKEM Blue Disease Sepsis and septic shock Trial question What is the role of early adjunctive methylene blue in patients with septic shock? Study design Single center Double blinded RCT Population Characteristics of study participants 40.0% female N = 91 60.0% male 91 patients (36 female, 55 male) Inclusion criteria: adult patients with septic shock according to Sepsis-3 criteria Key exclusion criteria: > 24 hours since initiation of norepinephrine; pregnancy; high probability of death within 48 hours; concurrent hemorrhagic, obstructive or hypovolemic shock; pending damage control surgery; major burn injury Interventions N=45 methylene blue (intravenous infusion at a dose of 100 mg in 500 mL of 0.9% sodium chloride solution for 6 hours once a day for a total of 3 doses) N=46 placebo (intravenous infusion of 500 mL of 0.9% sodium chloride solution for 6 hours once a day for a total of 3 doses) https://web.pathway.md/studies/recEu3HuldvHskcwK 1/2 6/29/23, 11:42 PM SHOCKEM-Blue Pathway Primary outcome Time to vasopressor discontinuation at day 28 94.0 hours 94 70.5 hours 69 47.0 hours 23.5 hours Significant decrease 0.0 hours Methylene blue Placebo Significant decrease in time to vasopressor discontinuation at day 28 (69 hours vs. 94 hours; AD -25 hours, 95% CI -39.83 to -10.17) Secondary outcomes Significant increase in median vasopressor-free days at 28 days (23.9 days vs. 19.5 days; MD 4.4, 95% CI 1.15 to 7.65) Significant decrease in hospital length of stay (9 days vs. 10.5 days; AD -1.5 days, 95% CI -2.83 to -0.17) No significant difference in death at day 28 (33% vs. 46%; RR 0.76, 95% CI 0.55 to 1.05) Safety outcomes No significant differences in ejection fraction, serum creatinine, bilirubin, and liver aminotransferases. Significant difference in metHgb saturation (2.9% vs. 0.5%). Conclusion In adult patients with septic shock according to Sepsis-3 criteria, methylene blue was superior to placebo with respect to time to vasopressor discontinuation at day 28. Reference Miguel Ibarra-Estrada, Eduardo Kattan, Pavel Aguilera-Gonz lez et al. Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial. Crit Care. 2023 Mar 13;27(1):110. Open reference URL https://web.pathway.md/studies/recEu3HuldvHskcwK 2/2