NCT07264543 Early Methylene Blue in the Microhemodynamics of Septic Patients
| NCT ID | NCT07264543 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-01-09 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2026-01-09 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 must be less than 5 weeks ago), * Recent intake (less than 2 weeks ago) of monoamine oxidase inhibitors (MAOIs), such as rasagiline and selegiline.
Contact & Investigator
Álvaro Réa-Neto
STUDY CHAIR
CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva
Frequently Asked Questions
Who can join the NCT07264543 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07264543 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07264543 currently recruiting?
Yes, NCT07264543 is actively recruiting participants. Contact the research team at brunadalvesco@gmail.com for enrollment information.
Where is the NCT07264543 trial being conducted?
This trial is being conducted at Curitiba, Brazil.
Who is sponsoring the NCT07264543 clinical trial?
NCT07264543 is sponsored by Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva. The principal investigator is Álvaro Réa-Neto at CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva. The trial plans to enroll 50 participants.