Methylene Blue for the Treatment of Septic Shock

Last updated: January 3, 2026
Sponsor: Northern Jiangsu People's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Sepsis And Septicemia

Low Blood Pressure (Hypotension)

Treatment

Placebo

Methylene Blue

Clinical Study ID

NCT06532240
2024ky202
  • Ages 18-90
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of methylene blue among adult patients with septic shock.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. age 18 years old or older;

  2. diagnosis of septic shock within 12 h.

Exclusion

Exclusion Criteria:

  1. recent intake (4-weeks) of selective serotonin re-uptake inhibitors;

  2. pregnant;

  3. definitive pulmonary hypertension or chronic pulmonary heart disease;

  4. known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;

  5. known allergy to methylene blue, phenothiazines, or food dyes;

  6. anticipated death from a preexisting disease within 90 days after randomization (asdetermined by the enrolling physician);

  7. refusal of the attending staff or patient family;

  8. participated in other study.

Study Design

Total Participants: 76
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
August 05, 2024
Estimated Completion Date:
January 31, 2026

Study Description

Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.

A potential benefit of methylene blue in the treatment of septic shock has recently been described by Estrada. In patients with septic shock, methylene blue initiated within 24 h reduced time to vasopressor discontinuation and increased vasopressor-free days at 28 days. It also reduced length of stay in ICU and hospital without adverse effects.

In this randomized controlled trial, we aim to evaluate the efficacy and safety of methylene blue on septic shock.

Connect with a study center

  • Northern Jiangsu people's hospital

    Yangzhou, Jiangsu 225000
    China

    Site Not Available

  • Northern Jiangsu people's hospital

    Yangzhou 1787227, Jiangsu 1806260 225000
    China

    Active - Recruiting

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