Early Methylene Blue in the Microhemodynamics of Septic Patients (NCT07264543) | Clinical Trial Compass
RecruitingPhase 2/3
Early Methylene Blue in the Microhemodynamics of Septic Patients
Brazil50 participantsStarted 2026-01-09
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 must be less than 5 weeks ago),
* Recent intake (less than 2 weeks ago) of monoamine oxidase inhibitors (MAOIs), such as rasagiline and selegiline.
What they're measuring
1
To evaluate the feasibility of the study protocol.
Timeframe: 28 days after randomization.
Trial details
NCT IDNCT07264543
SponsorCentro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva