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Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Sponsor: First Affiliated Hospital of Zhejiang University
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.
Official title: Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
Any - Any
Study Type
INTERVENTIONAL
Enrollment
488
Start Date
2024-06-22
Completion Date
2026-06-20
Last Updated
2024-12-30
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China