RecruitingNot ApplicableNCT06481410

Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock

Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial

Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

488 participants

Start Date

Jun 22, 2024

Study Type

INTERVENTIONAL

Conditions

Sepsis Septic Shock Methylene Blue

Summary

The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock, shorten the duration of norepinephrine use, reduce the dosage of vasopressors, promptly correct hemodynamics, and improve tissue perfusion and organ function impairment.

Eligibility

Inclusion Criteria4

Age ≥ 18 years.
Meets the Sepsis 3.0 criteria for septic shock: patients with infection who, despite adequate fluid resuscitation, require vasopressor therapy to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg and have a blood lactate concentration > 2 mmol/L.
Diagnosed with septic shock and started on norepinephrine within 24 hours.
Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.

Exclusion Criteria5

Pregnant or breastfeeding women.
Individuals allergic to methylene blue or any components of the methylene blue injection.
Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Patients with an expected survival time of less than 48 hours.
Patients who have been on norepinephrine for more than 24 hours.

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Interventions

DRUGMethylene Blue Intervention Group

In addition to standard treatment, patients will receive methylene blue intervention. The method is as follows: a loading dose of 2.5 mg/kg administered via micro-pump over 15 minutes, followed by a continuous infusion at a rate of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first. If norepinephrine needs to be increased to 0.1 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.

DRUGNormal Saline Control Group

In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.