SHOCKEM-Blue
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
60.0% male
N = 91
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)
Primary outcome
Time to discontinuation of vasopressors at day 28
69
94
94.0 hours
70.5 hours
47.0 hours
23.5 hours
0.0 hours
Methylene
blue
Placebo
Significant
decrease ▼
Significant decrease in time to discontinuation of vasopressors 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 methemoglobin 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 discontinuation of vasopressors at day 28.
Reference
Miguel Ibarra-Estrada, Eduardo Kattan, Pavel Aguilera-González et al. Early adjunctive methylene blue in patients with septic shock: a randomized controlled trial. Crit Care. 2023 Mar 13;27(1):110.
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