Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital of Zhejiang University
About this trial
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
Qualifiers
Age ≥ 18 years.
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.
Diagnosed with septic shock and started on norepinephrine within 24 hours.
Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.
Disqualifiers
Pregnant or breastfeeding women.
Individuals allergic to methylene blue or any components of the methylene blue injection.
Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
Patients with an expected survival time of less than 48 hours.
Trial design
Treatments tested in this trial
- Methylene Blue Intervention Group
- Normal Saline Control Group
Treatment groups
488 Participants
are divided into 2 treatment groupsSponsors and collaborators
First Affiliated Hospital of Zhejiang University
Lead sponsor
Yuyao People's Hospital
Collaborator
Taizhou Enze Medical Center Group
Collaborator
Ningbo Medical Center Lihuili Hospital
Collaborator
People's Hospital of Guangxi Zhuang Autonomous Region
Collaborator
The second Nanning People's Hospital
Collaborator
GUI LIN PEOPLE'S HOSPITAL
Collaborator
First Affiliated Hospital, Sun Yat-Sen University
Collaborator
The First People's Hospital of Huzhou
Collaborator
Hangzhou Yuhang District Second People's Hospital
Collaborator
Wuming Hospital of Guangxi Medical University
Collaborator
Source ClinicalTrials.gov