Using methylene blue to treat severe septic shock
Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial
NA · First Affiliated Hospital of Zhejiang University · NCT06481410
This study is testing if methylene blue can help people with severe septic shock survive better and improve their organ function compared to a placebo.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 488 (estimated) |
| Sex | All |
| Sponsor | First Affiliated Hospital of Zhejiang University (other) |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06481410 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy and safety of methylene blue injection in patients suffering from severe septic shock. Participants will receive either methylene blue or a placebo, and the study aims to determine if methylene blue can improve survival rates, reduce the need for vasopressors, and enhance organ function. Key measurements will include mortality rates and various hemodynamic parameters over a 28-day period. The trial will also monitor the duration of norepinephrine use and other critical health indicators.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who meet the Sepsis 3.0 criteria for septic shock and require norepinephrine therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions such as G6PD deficiency may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve survival rates and recovery outcomes for patients with severe septic shock.
How similar studies have performed: While the use of methylene blue in this context is being explored, similar studies have shown promise in treating septic shock with various interventions, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years. 2. Meets the Sepsis 3.0 criteria for septic shock: patients with infection who, despite adequate fluid resuscitation, require vasopressor therapy to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg and have a blood lactate concentration \> 2 mmol/L. 3. Diagnosed with septic shock and started on norepinephrine within 24 hours. 4. Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg. Exclusion Criteria: 1. Pregnant or breastfeeding women. 2. Individuals allergic to methylene blue or any components of the methylene blue injection. 3. Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency. 4. Patients with an expected survival time of less than 48 hours. 5. Patients who have been on norepinephrine for more than 24 hours.
Where this trial is running
Hangzhou, Zhejiang
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Study coordinator: Wenqiao Yu, PhD
- Email: yuwenqiao1980@zju.edu.cn
- Phone: +86-18868787588
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.
Conditions: Septic Shock, Methylene Blue, Sepsis, Methylene blue