NCT06481410 Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
| NCT ID | NCT06481410 |
| Status | Recruiting |
| Phase | — |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 488 participants |
| Start Date | 2024-06-22 |
| Primary Completion | 2026-06-20 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 488 participants in total. It began in 2024-06-22 with a primary completion date of 2026-06-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock, shorten the duration of norepinephrine use, reduce the dosage of vasopressors, promptly correct hemodynamics, and improve tissue perfusion and organ function impairment.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06481410 clinical trial?
This trial is open to participants of all sexes, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06481410 currently recruiting?
Yes, NCT06481410 is actively recruiting participants. Contact the research team at yuwenqiao1980@zju.edu.cn for enrollment information.
Where is the NCT06481410 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06481410 clinical trial?
NCT06481410 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 488 participants.