Early Methylene Blue in the Microhemodynamics of Septic Patients
Recruiting now · Phase 2/Phase 3
Conditions studied: Septic Shock, Hypoperfusion
In brief
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.
Key facts
- Study ID
- NCT07264543
- Run by
- Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva
- People needed
- 50
- Starts
- 2026-01-09
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-03-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Irmandade da Santa Casa de Misericórdia de Curitiba — Curitiba, Paraná, Brazil (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.