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Recruiting Phase 2, Phase 3 NCT07264543

Early Methylene Blue in the Microhemodynamics of Septic Patients

Trial Parameters

Condition Septic Shock
Sponsor Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
Study Type INTERVENTIONAL
Phase Phase 2, Phase 3
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2026-01-09
Completion 2026-11-30
Interventions
Methylene blue infusion

Brief Summary

The aim of the study is to evaluate the viability and feasibility of its protocol in order to conduct a larger clinical trial to assess whether methylene blue can improve patient-centered clinical outcomes such as mortality or length of hospital stay in septic shock patients.

Eligibility Criteria

Inclusion Criteria: * Adult patients with a diagnosis of sepsis and persistent hemodynamic dysfunction despite adequate fluid resuscitation, requiring escalation of noradrenaline dose to maintain mean arterial pressure ≥65 mmHg, with prolonged capillary refill time or septic shock according to Sepsis-3 definition, within less than 6 hours of the diagnosis, will be eligible for the study. Exclusion Criteria: * Pregnant or breastfeeding patients; * Patients with any withdrawal or withholding life-sustaining intervention; * Cardiac surgery patients in the immediate postoperative period; * Refractory septic shock, with a high propability of death within 24 hours; * Personal or familiar history of glucose-6-phosphate dehydrogenase (G6PD) deficiency; * Allergy to methylene blue, phenothiazines, or food dyes; * Recent administration of linezolid (less than 14 days ago); * Recent intake of serotonergic psychiatric medications (less than 2 weeks ago - with the exception of fluoxetine, which mus

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