Using methylene blue to treat septic shock
Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial
This study tests if methylene blue can help adults with septic shock recover faster and spend fewer days needing medication to support their blood pressure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Northern Jiangsu People's Hospital Academic / other |
| Locations | 1 site (Yangzhou, Jiangsu) |
| Trial ID | NCT06532240 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of methylene blue in adult patients diagnosed with septic shock. The study aims to determine if methylene blue can reduce the time to vasopressor discontinuation and increase the number of vasopressor-free days at 28 days post-treatment. Participants will be randomly assigned to receive either methylene blue or a placebo. The trial is designed to assess both the clinical outcomes and any potential adverse effects associated with the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have been diagnosed with septic shock within the last 12 hours.
Not a fit: Patients with recent intake of selective serotonin re-uptake inhibitors, pregnant individuals, or those with specific pre-existing conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve recovery times and reduce mortality rates in patients suffering from septic shock.
How similar studies have performed: Previous studies have indicated potential benefits of methylene blue in treating septic shock, suggesting that this approach may be promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age 18 years old or older; 2. diagnosis of septic shock within 12 h. Exclusion Criteria: 1. recent intake (4-weeks) of selective serotonin re-uptake inhibitors; 2. pregnant; 3. definitive pulmonary hypertension or chronic pulmonary heart disease; 4. known glucose-6 phosphate dehydrogenase (G-6PD) deficiency; 5. known allergy to methylene blue, phenothiazines, or food dyes; 6. anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician); 7. refusal of the attending staff or patient family; 8. participated in other study.
Where this trial is running
Yangzhou, Jiangsu
- Northern Jiangsu people's hospital — Yangzhou, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Qingquan Lyu, Master — Northern Jiangsu People's Hospital
- Study coordinator: Qingquan Lyu, Master
- Email: bonhomie2014@163.com
- Phone: 0086-18051063899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.