Early Methylene Blue in the Microhemodynamics of Septic Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Methylene blue infusion.
- Who it may be relevant to
- Registry conditions: Septic Shock, Hypoperfusion. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluation of Early Methylene Blue in the Microhemodynamics of Septic Patients: a Feasibility Randomized Controlled Trial
Overview
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.
Detailed description
One of the primary causes of high mortality in patients with septic shock is microcirculatory dysfunction related to vasodilation caused by excessive oxide nitric production. It has been shown that methylene blue, an old and safe drug that can reduce vasodilation by blocking nitric oxide pathways, is a vasopressor-sparing treatment in sepsis. Nevertheless, there is no evidence that methylene blue improves patient-centered clinical outcomes such as mortality. Understanding how early methylene blue affects the microhemodynamics of septic shock patients may lead to relevant clinical results that can improve their prognosis. So, the objective of the study is to evaluate the viability and feasibility of the study protocol for a larger clinical trial, assessing the effectiveness of early methylene blue in the microhemodynamics of septic shock patients, mainly through the capillary refill time measurement. For this purpose, a pilot study of an open-label, randomized, controlled and single-center clinical trial will be conducted, with two treatment arms: the intervention group (methylene blue plus standard treatment) and the control group (standard treatment). Fifty adult patients with septic shock within the first six hours of diagnosis will be included in this study. They will be randomized to either receive a methylene blue infusion or not. The randomization will be conducted using RedCap with a 1:1 ratio and variable block sizes. The primary outcome will be to assess the feasibility, which is defined as completing the study recruitment within the 12-month timeline and achieving protocol adherence of 90% or higher. Comparisons between groups for serially measured micro and macrohemodynamics parameters will be the secondary outcomes. Additionally, the incidence of adverse events related to methylene blue will be monitored.
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 stu
Primary outcome measures
- To evaluate the feasibility of the study protocol. [Time frame: 28 days after randomization.]
Secondary outcome measures (10)
- Capillary refill time [Time frame: 72 hours after randomization.]
- Serum lactate level [Time frame: 72 hours after randomization.]
- Arteriovenous carbon dioxide difference (gapCO2) [Time frame: 72h after randomization.]
- Central venous oxygen saturation (SvO2) [Time frame: 72h after randomization.]
- Serial measurements of heart rate [Time frame: 72 hours after randomization.]
- Serial measurements of mean arterial pressure [Time frame: 72 hours after randomization.]
- Serial measurements of pulse pressure [Time frame: 72 hours after randomization.]
- Serial measurements of systolic arterial pressure [Time frame: 72 hours after randomization.]
- Serial measurements of dyastolic arterial pressure [Time frame: 72 hours after randomization.]
- Methylene blue-related adverse events [Time frame: 28 days after randomization.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- Irmandade da Santa Casa de Misericórdia de Curitiba — Curitiba
Identifiers
NCT: NCT07264543 · U1111-1331-7627 · Approval number 7.955.174 · CAAE 93099325.5.0000.0020