Northern Jiangsu people's hospital
Yangzhou, Jiangsu, 225000, China
NCT Number: NCT06532240
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
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Notify Me18 year–90 year
All sexes
Interventional
Phase 3
Yangzhou, Jiangsu, 225000, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: 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.
Other names: 5%GS
Time frame: 90 days after randomization
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: 28 days after randomization
All-cause mortality at day 28 after randomization
Time frame: 90 days after randomization
All-cause mortality at day 90 after randomization
Time frame: 90 days after randomization
All-cause mortality at ICU discharge
Time frame: 90 days after randomization
All-cause mortality at hospital discharge
Time frame: 90 days after randomization
Time in days until ICU discharge
Time frame: 90 days after randomization
Time in days until hospital discharge
Time frame: 28 days after randomization
Total number of days alive and free of ICU stay during the 28 days after randomization.
Time frame: 28 days after randomization
Total number of days alive and free of vasopressor during the 28 days after randomization.
Time frame: 28 days after randomization
Total number of days alive and free of ventilator support during the 28 days after randomization.
Time frame: 28 days after randomization
Total number of days alive and free of CRRT during the 28 days after randomization.
Time frame: 72 hours after randomization
lactate level at 72h after randomization
Time frame: 72 hours after randomization
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
P/F at 72h after randomization
Northern Jiangsu People's Hospital
Other
Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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