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Early Methylene Blue in the Microhemodynamics of Septic Patients

NCT07264543 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-03-27

No results posted yet for this study

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.

Conditions

  • Septic Shock
  • Hypoperfusion

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.

Sponsors & Collaborators

  • Irmandade da Santa Casa de Misericordia de Curitiba

    collaborator OTHER

  • Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva

    lead OTHER

Principal Investigators

  • Álvaro Réa-Neto · CEPETI - Centro de Estudos e Pesquisa em Emergências Médicas e Terapia Intensiva

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-09
Primary Completion
2026-11-30
Completion
2026-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07264543 on ClinicalTrials.gov