NCT06532240

Methylene Blue for the Treatment of Septic Shock

Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Northern Jiangsu People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.

Detailed description

Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide. A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects. In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	Methylene Blue	Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first.
DRUG	Placebo	An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-10-24
• Completion: 2025-10-24
• First posted: 2024-08-01
• Last updated: 2026-02-04

Locations

1 site across 1 country: China