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

Condition(s) studied

Investigational drug(s) / intervention(s)

Methylene 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.

Normal 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.

Study 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

Primary outcome measure(s)

• 28-day survival rate of enrolled patients — 28-day
  Our primary endpoint is the 28-day survival rate of enrolled patients: All enrolled patients will be followed from the time of randomization until 28 days post-enrollment, recording the survival status on the 28th day after enrollment. If a patient dies within 28 days post-enrollment, the number of survival days will be recorded. Note: 1. Cases where the family requests discharge to home for end-of-life care and the patient subsequently dies will be counted as death cases. 2. Cases where the family requests discharge for non-medical reasons such as financial constraints and no further treatment is sought will be counted as dropout cases.

Trial sites (1)

More First Affiliated Hospital of Zhejiang University trials in China

Other trials for the same condition