Septic Shock
Conditions
Interventions
Methylene Blue Group:Drug Preparation: 10 vials of methylene blue injection (2ml, 20mg each) diluted with 5% glucose solution [ref needed?] to a concentration of 2 mg/ml (50ml syringe).
Loading Dose:
Control Group:Equal volume of 5% glucose solution.
Infusion regimen (loading and maintenance) identical in rate and duration to the intervention group.
Sponsors
Sichuan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years; 2.Meet the Sepsis-3 criteria for septic shock: Suspected or confirmed infection; Require norepinephrine to maintain mean arterial pressure (MAP) >= 65 mmHg; Blood lactate > 2 mmol/L despite adequate fluid resuscitation. 3.Within 24 hours of initiating norepinephrine. 4.At screening for enrollment, the equivalent norepinephrine dose exceeds 0.3 µg/kg/min for more than 30 minutes.
Exclusion criteria
Exclusion criteria: 1.Pregnancy or lactation; 2.Severe acute hypoxemic respiratory failure (PaO2/FiO2 20% body surface area); 7.Glucose-6-phosphate dehydrogenase deficiency; 8.Known allergy to methylene blue, phenothiazines, or food colorings; 9.Recent (within 4 weeks) use of serotonergic drugs (e.g., SSRIs, SNRIs, MAO inhibitors); 10.Patient or legal representative refuses consent. 11.Prior use of methylene blue in the current episode of illness.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 28-day all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| ICU survival days within 28 days;Number of days off antihypertensive medications within 28 days;Number of ventilator-free days within 28 days;In-hospital mortality rate;48-hour cumulative fluid balance;Absolute decrease in SOFA score; | — |
Countries
China
Contacts
Public ContactChun Pan
Sichuan Provincial People's Hospital
Outcome results
None listed