Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Jun 27, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how well methylene blue, a medication given through injection, can help patients who are experiencing severe septic shock. Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and reduced blood flow to vital organs. The trial aims to see if methylene blue can improve survival rates, reduce the need for other medications like norepinephrine (which helps raise blood pressure), and improve overall organ function.

To participate in this trial, you must be at least 18 years old and diagnosed with septic shock, requiring a specific level of norepinephrine to maintain stable blood pressure. Unfortunately, pregnant or breastfeeding women, individuals with certain allergies, or those with specific health conditions may not be eligible. If you choose to enroll, you will receive methylene blue as part of your treatment and be monitored closely to assess how well it works and its safety. This study is currently looking for participants, so if you or a loved one meet the criteria, it could be an important opportunity to help improve treatment for this critical condition.

Gender

ALL

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.