What this Trial Is About

This research aims to evaluate the safety and effectiveness of methylene blue injection in patients with severe septic shock. The study seeks to determine if methylene blue can improve survival rates, shorten the use of norepinephrine, reduce vasopressor dosage, quickly correct blood flow and pressure issues, and improve tissue and organ function. It compares methylene blue to a placebo to assess its impact in this critical condition. Participants will be randomly assigned to receive either methylene blue or a placebo in addition to standard treatment. Those in the methylene blue group will receive a loading dose of 2.5 mg/kg through a micro-pump over 15 minutes, followed by a continuous infusion of 0.25 mg/kg per hour for up to 12 hours or until norepinephrine has been stopped for 4 hours, whichever occurs first. If norepinephrine levels increase before 12 hours, methylene blue treatment continues until the full 12-hour infusion is completed. The placebo group will receive an equivalent infusion of normal saline for the same period. During the study, researchers will monitor patients' survival over 28 days and record the time needed to stop norepinephrine, total norepinephrine dose, days without norepinephrine, duration of mechanical ventilation, use of kidney replacement therapy, and lengths of ICU and hospital stays. Blood and organ function markers such as lactate, blood pressure, liver enzymes, kidney function, oxygen levels, and heart injury markers will be measured before treatment and at 24 hours, 72 hours, and 5 days after intervention to assess the effects and safety of the treatment.

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