Actively Recruiting

Phase Not Applicable
All Genders
NCT06481410

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

Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-30

488

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

Sponsors

F

First Affiliated Hospital of Zhejiang University

Lead Sponsor

Y

Yuyao People's Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosis of septic shock meeting Sepsis 3.0 criteria requiring vasopressor therapy to maintain mean arterial pressure ≥ 65 mmHg with blood lactate > 2 mmol/L
  • Started norepinephrine treatment within 24 hours of septic shock diagnosis
  • Requires norepinephrine dose of at least 0.1 µg/kg/min to maintain mean arterial pressure ≥ 65 mmHg
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Allergic to methylene blue or its injection components
  • Personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
  • Expected survival time less than 48 hours
  • On norepinephrine treatment for more than 24 hours

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

W

Wenqiao Yu, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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