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RECRUITING
NCT07264543
PHASE2/PHASE3

Early Methylene Blue in the Microhemodynamics of Septic Patients

Sponsor: Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva

View on ClinicalTrials.gov

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.

Official title: Evaluation of Early Methylene Blue in the Microhemodynamics of Septic Patients: a Feasibility Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-01-09

Completion Date

2026-12-31

Last Updated

2026-03-27

Healthy Volunteers

No

Interventions

DRUG

Methylene blue infusion

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)

Irmandade da Santa Casa de Misericórdia de Curitiba

Curitiba, Paraná, Brazil