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

Sponsored by First Affiliated Hospital of Zhejiang University

About this trial

Last updated a year ago

Study ID

2024-051

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

Accepting

All Ages

All Sexes

Trial Timing

Started 2 years ago

What is this trial about?

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.

What are the participation requirements?

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.