A Phase 3 interventional study of Methylene Blue and Placebo in Septic Shock, sponsored by Northern Jiangsu People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Northern Jiangsu People's Hospital · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
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.
862 studies on the registry are indexed under Shock, Septic; 206 are open to participants now.
This study's enrollment of 88 is above the median of 79 across 529 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Northern Jiangsu People's Hospital is the lead sponsor of 60 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first).
Drug: Methylene Blue
5% dextrose solution in a volume to match experimental arm component.
Drug: Placebo
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.
Also known as: MB
An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.
Also known as: 5%GS
Time to shock reversal
Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h.
Time frame: 90 days after randomization
28-day mortality
All-cause mortality at day 28 after randomization
Time frame: 28 days after randomization
90-day mortality
All-cause mortality at day 90 after randomization
Time frame: 90 days after randomization
ICU mortality
All-cause mortality at ICU discharge
Time frame: 90 days after randomization
Hospital mortality
All-cause mortality at hospital discharge
Time frame: 90 days after randomization
ICU length of stay
Time in days until ICU discharge
Time frame: 90 days after randomization
hospital length of stay
Time in days until hospital discharge
Time frame: 90 days after randomization
ICU-free days up to day 28
Total number of days alive and free of ICU stay during the 28 days after randomization.
Time frame: 28 days after randomization
vasopressor-free days up to day 28
Total number of days alive and free of vasopressor during the 28 days after randomization.
Time frame: 28 days after randomization
ventilator support-free days up to day 28
Total number of days alive and free of ventilator support during the 28 days after randomization.
Time frame: 28 days after randomization
CRRT-free days up to day 28
Total number of days alive and free of CRRT during the 28 days after randomization.
Time frame: 28 days after randomization
72h lactate
lactate level at 72h after randomization
Time frame: 72 hours after randomization
72h Delta SOFA
Initial SOFA score at enrollment-SOFA score after 72 h;If the patient discharged within 72 h after being enrolled in the study, the SOFA score at discharge was used for the analysis.
Time frame: 72 hours after randomization
72h P/F
P/F at 72h after randomization
Time frame: 72 hours after randomization
Plan to share: No
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Northern Jiangsu People's Hospital