Using methylene blue to treat severe septic shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.