Skip to content

Efficacy and Safety of Methylene Blue in the Treatment of Refractory Septic Shock: a Multicenter, Randomized, Placebo-Controlled Clinical Trial

Efficacy and Safety of Methylene Blue in the Treatment of Refractory Septic Shock: a Multicenter, Randomized, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069430
Enrollment
Unknown
Registered
2023-03-16
Start date
2023-03-16
Completion date
Unknown
Last updated
2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

Placebo Control Group:5% Glucose Intravenous Injection and Standard Treatment

Sponsors

General Hospital of Southern Theatre Command
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients aged 18 years and over; 2. Diagnosed as septic shock based on of Sepsis-3 definition from the international consensus published in 2021. This definition includes suspected or confirmed infections, an increase in Sequential Organ Failure Assessment (SOFA) score by 2 or more points, the need for vasopressor therapy due to hypotension, and a lactate level greater than 2 mmol/L; 3. Conformed to refractory septic shock, which is defined in this trial as septic shock requiring a continuous infusion of norepinephrine greater than 0.5 ug/kg/min or an equivalent dose of other vasopressors to maintain mean arterial pressure (MAP) greater than 65 mmHg; 4. Initially diagnosed as refractory septic shock in research hospitals.

Exclusion criteria

Exclusion criteria: 1. Patients in pregnancy or lactation; 2. Allergic to methylene blue; 3. With glucose-6-phosphate-dehydrogenase deficiency; 4. With terminal malignant cancer; 5. With non-infectious risk factors leading to death such as uncontrollable hemorrhea, brain hernia; 6. With irreversible disease or in terminal stage; 7. Refusing active treatment or planning to leave ICUs within 48 hours; 8. Enrolled in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Total dose of vasopressors;

Secondary

MeasureTime frame
Blood Pressure;Heart Rate;Hemodynamic indexes;Oxygen metabolism indexes;Tissue perfusion indexes;Major organ function indexes;Plasma cytokines and other factors;

Countries

China

Contacts

Public ContactZhifeng Liu

General Hospital of Southern Theatre Command of People's Liberation Army

zhifengliu7797@163.com+86 13711598120

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026