Early Methylene Blue in the Microhemodynamics of Septic Patients

NCTNCT07264543Other idU1111-1331-7627Other idApproval number 7.955.174Other idCAAE 93099325.5.0000.0020

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 2/3
Enrollment: 50 participants (estimated)
Sponsor: Centro de Estudos e Pesquisa em Emergencias Medicas e Terapia Intensiva · Other
Design: Randomized · Single masking
Countries: 1 country
Brazil
Start: 9 Jan 2026
Primary completion: 30 Nov 2026 (estimated)
Completion: 31 Dec 2026 (estimated)
First posted: 4 Dec 2025
Last update posted: 27 Mar 2026
Conditions: Septic Shock · Hypoperfusion

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20262027

Ph 2/3
Early Methylene Blue in the Microhemodynamics of Septic Patients
NCT07264543
9 Jan 2026 to est. 31 Dec 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

Methylene blue infusionDrug

Arms2

Experimental
Methylene blue group
The intervention group will receive methylene blue plus standard treatment for septic shock, according to the international guidelines.
No intervention
Control group
The control group will receive the standard treatment according to international guidelines for the management of sepsis and septic shock.

Primary outcomes1

Outcomes the sponsor listed as primary.

To evaluate the feasibility of the study protocol.
Time frame · 28 days after randomization.
Registry description
The primary outcome of the study is to evaluate feasibility, defined as completing the study protocol according to the planned timeline and with 90% or more protocol adherence. Protocol adherence will be defined as the use of the allocated therapy in the intervention group for 6 hours for 3 days (or interruption of methylene blue if the patient does not require a vasoactive drug anymore). Justified interruptions will not be considered violations.

Secondary outcomes(10)

Capillary refill time
Time frame · 72 hours after randomization.
Registry description
Serial capillary refill time from randomization up to 72 hours later.
Serum lactate level
Time frame · 72 hours after randomization.
Registry description
Serial measurements of serum lactate level during the 72 hours after randomization.
Arteriovenous carbon dioxide difference (gapCO2)
Time frame · 72h after randomization.
Registry description
Serial measurements of arteriovenous carbon dioxide difference (gapCO2) during 72h after randomization.
Central venous oxygen saturation (SvO2)
Time frame · 72h after randomization.
Registry description
Serial measurements of central venous oxygen saturation (SvO2) during 72h after randomization.
Serial measurements of heart rate
Time frame · 72 hours after randomization.
Registry description
Serial measurements of heart rate from randomization up to 72 hours later.
Serial measurements of mean arterial pressure
Time frame · 72 hours after randomization.
Registry description
Serial measurements of mean arterial pressure from randomization up to 72 hours later.
Serial measurements of pulse pressure
Time frame · 72 hours after randomization.
Registry description
Serial measurements of pulse pressure from randomization up to 72 hours later.
Serial measurements of systolic arterial pressure
Time frame · 72 hours after randomization.
Registry description
Serial measurements of systolic arterial pressure from randomization up to 72 hours later.
Serial measurements of dyastolic arterial pressure
Time frame · 72 hours after randomization.
Registry description
Serial measurements of dyastolic arterial pressure from randomization up to 72 hours later.
Methylene blue-related adverse events
Time frame · 28 days after randomization.
Registry description
Incidence of adverse events during the three days of administration of methylene blue and up to 28 days after.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

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.

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