Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital, Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
Wenqiao Yu, PhD
yuwenqiao1980@zju.edu.cn
+86-18868787588
Time Frame
Start Date: 2024-06-22
Estimated Completion Date: 2026-06-20
Participants
Target number of participants: 488
Treatments
Experimental: Methylene Blue Intervention Group
Methylene blue injection, 2.5 mg/kg loading dose over 15 minutes, followed by a continuous infusion of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first.
Placebo_comparator: Normal Saline Control Group
Normal saline solution, administered in the same manner and duration as the methylene blue intervention.
Related Therapeutic Areas
Sponsors
Collaborators: The second Nanning People's Hospital, Taizhou Enze Medical Center Group, Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University, People's Hospital of Guangxi Zhuang Autonomous Region, Wuming Hospital of Guangxi Medical University, NINGBO MEDICAL CENTER LIHUIIHOSPITAI, Yuyao People's Hospital, GUI LIN PEOPLE'S HOSPITAL, Hangzhou Yuhang District Second People's Hospital, The First People's Hospital of Huzhou
Leads: First Affiliated Hospital of Zhejiang University

This content was sourced from clinicaltrials.gov