Methylene Blue for the Treatment of Septic Shock
- Registration Number
- NCT06532240
- Lead Sponsor
- Northern Jiangsu People's Hospital
- Brief Summary
The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 76
- age 18 years old or older;
- diagnosis of septic shock within 12 h.
- recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
- pregnant;
- definitive pulmonary hypertension or chronic pulmonary heart disease;
- known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
- known allergy to methylene blue, phenothiazines, or food dyes;
- anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
- refusal of the attending staff or patient family;
- participated in other study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Methylene Blue Methylene Blue 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). Placebo Placebo 5% dextrose solution in a volume to match experimental arm component.
- Primary Outcome Measures
Name Time Method Time to shock reversal 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.
- Secondary Outcome Measures
Name Time Method 28-day mortality 28 days after randomization All-cause mortality at day 28 after randomization
ICU mortality 90 days after randomization All-cause mortality at ICU discharge
90-day mortality 90 days after randomization All-cause mortality at day 90 after randomization
Hospital mortality 90 days after randomization All-cause mortality at hospital discharge
Trial Locations
- Locations (1)
Northern Jiangsu people's hospital
🇨🇳Yangzhou, Jiangsu, China