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

IIT20240034C

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.

2024-06-20

2026-06-20

2026-06-20

Not yet recruiting

488

Inclusion Criteria: 1. Age ≥ 18 years. 2. 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. 3. Diagnosed with septic shock and started on norepinephrine within 24 hours. 4. Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Individuals allergic to methylene blue or any components of the methylene blue injection. 3. Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency. 4. Patients with an expected survival time of less than 48 hours. 5. Patients who have been on norepinephrine for more than 24 hours.

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2024-07-01