Methylene blue as an adjunctive therapy could be one of the strategies for septic shock to reduce vasopressor. Methylene blue, Septic shock, Adjunctive therapy
Conditions
Interventions
A pilot double-blind, allocation-concealed, placebo-controlled single-center randomized controlled trial
randomized 1:1
In the experimental arm: 100 mg of methylene blue in 5%DW 100 mL IV over 6 hours once daily for up to 3 doses (or until discontinuous of vasopressor if sooner) ,In the placebo arm: 5%
Active Comparator Drug,Placebo Comparator Drug
Methylene blue,5%DW
Sponsors
Faculty of Medicine, Prince of Songkla University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Patients 18 years or older with septic shock defined by Sepsis-3 criteria and serum lactate more than 2 mmol/L, which has all of the following 1. received intravenous crystalloid resuscitation at least 30 mL/kg 2. requiring at least 0.25 micrograms/kg/min of norepinephrine equivalent to maintain mean arterial blood pressure at least 65 mmHg 3. received at least one dose of corticosteroids equivalent to hydrocortisone 50 mg
Exclusion criteria
Exclusion criteria: 1. Longer than 24 hours since norepinephrine initiation 2. High probability of death within 48 hours 3. Plan for best supportive care 4. Second episode of septic shock during the study 5. Combined with other causes of shock, which were diagnosed by research team, such as obstructive shock, cardiogenic shock is defined as evidence of shock resulting from a cardiac event, such as acute myocardial infarction, valvular dysfunction, or cardiomyopathy. It is typically accompanied by clinical presentation and laboratory findings, including an electrocardiogram (ECG), chest radiography, echocardiogram, or cardiac enzyme levels. 6. Known allergy to methylene blue 7. Familial history of glucose-6-phosphate dehydrogenase (G6PD) deficiency or history of childhood hemolysis 8. Recent ongoing treatment of selective serotonin reuptake inhibitors (SSRI) or monoamine oxidase (MAO) inhibitors within 4 weeks 9. Body weight < 50 kilograms 10. Patient received extracorporeal membrane oxygenation (ECMO) 11. Chronic kidney disease stage 4-5 classified by Kidney Disease Improving Kidney Outcome (KDIGO) 2022
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| vasopressor free-days at 28 days after start intervention vasopressor free-days | — |
Secondary
| Measure | Time frame |
|---|---|
| change of SOFA score in day 1 and day 3 day 1 and day 3 post intervention SOFA score,ICU length of stay ICU length of stay since admission ICU length of stay ,hospital length of stay hospital length of stay since admission hospital length of stay,ventilator free-day at 28 days after start intervention ventilator free-day, all-cause mortality at 28 days at 28 days after start intervention all-cause mortality at 28 days,hemodynamic parameters at 6-24-48-72 hours at 6-24-48-72 hours after start intervention diastolic arterial pressure, mean arterial pressure (MAP), systemic vascular resistance (SVR), cardiac output (CO), systolic arterial pressure, heart rate, central venous pressure (CVP) | — |
Countries
Thailand
Contacts
Public ContactNatthaka Sathaporn
Faculty of Medicine
Outcome results
None listed