Early methylene blue to improve microcirculation in septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized, controlled, single-center pilot of 50 adult patients with septic shock enrolled within six hours of diagnosis. Participants are randomized 1:1 to receive an infusion of methylene blue plus standard care or standard care alone. The study focuses on early effects of methylene blue on microhemodynamics, using capillary refill time and related measures, and is designed to evaluate feasibility of the protocol for a larger trial. The trial will also record clinical outcomes such as vasopressor requirements, length of stay, and mortality to inform a subsequent definitive study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Irmandade da Santa Casa de Misericórdia de Curitiba
  Curitiba, Paraná, Brazil Recruiting

Study contacts

• Study coordinator: Bruna Dal Vesco
• Email: brunadalvesco@gmail.com
• Phone: +55 (41) 3362-6633

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.