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

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.

Conditions

• Septic Shock
• Methylene Blue
• Sepsis

Interventions

DRUG

Methylene Blue Intervention Group

In addition to standard treatment, patients will receive methylene blue intervention. The method is as follows: a loading dose of 2.5 mg/kg administered via micro-pump over 15 minutes, followed by a continuous infusion at a rate of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first. If norepinephrine needs to be increased to 0.1 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.

DRUG

Normal Saline Control Group

In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.

Sponsors & Collaborators

• Yuyao People's Hospital

  collaborator OTHER

• Taizhou Enze Medical Center Group

  collaborator OTHER

• NINGBO MEDICAL CENTER LIHUIIHOSPITAI

  collaborator UNKNOWN

• People's Hospital of Guangxi Zhuang Autonomous Region

  collaborator OTHER

• The second Nanning People's Hospital

  collaborator UNKNOWN

• GUI LIN PEOPLE'S HOSPITAL

  collaborator UNKNOWN

• Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University

  collaborator UNKNOWN

• The First People's Hospital of Huzhou

  collaborator OTHER

• Hangzhou Yuhang District Second People's Hospital

  collaborator UNKNOWN

• Wuming Hospital of Guangxi Medical University

  collaborator UNKNOWN

• First Affiliated Hospital of Zhejiang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-22

Primary Completion

2026-06-20

Completion

2026-06-20

Countries

• China

Study Locations