Early Methylene Blue in the Microhemodynamics of Septic Patients
Evaluation of Early Methylene Blue in the Microhemodynamics of Septic Patients: a Feasibility Randomized Controlled Trial
Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
50 participants
Jan 9, 2026
INTERVENTIONAL
Conditions
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
Inclusion Criteria1
- 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 Criteria9
- 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 must be less than 5 weeks ago),
- Recent intake (less than 2 weeks ago) of monoamine oxidase inhibitors (MAOIs), such as rasagiline and selegiline.
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Interventions
Methylene blue at a dose of 100mg (diluted in 100ml of 5% dextrose solution) in continuous infusion for 06 hours per day, for 03 days, plus standard treatment according to international guidelines for the management of sepsis and septic shock. The 03 consecutive MB infusions, each lasting 06 hours, will be performed every 24 hours, starting from randomization: the first infusion at T0, the second at T24, and the third at T48, considering T0 the moment after the patient randomization into the study. The interruption of the protocol will be recommended if vasopressors are completely discontinued during the three days of methylene blue infusion. The attending physician may discontinue methylene blue treatment if judges necessary. Similarly, interruption may occur if the family or patient request.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07264543