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Completed

NCT Number: NCT06532240

Methylene Blue for the Treatment of Septic Shock

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northern Jiangsu people's hospital

Yangzhou, Jiangsu, 225000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 years old or older;
  • diagnosis of septic shock within 12 h.

Exclusion criteria

  • recent intake (4-weeks) of selective serotonin re-uptake inhibitors;
  • pregnant;
  • definitive pulmonary hypertension or chronic pulmonary heart disease;
  • known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
  • known allergy to methylene blue, phenothiazines, or food dyes;
  • anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician);
  • refusal of the attending staff or patient family;
  • participated in other study.

Treatment and study plan

Methylene Blue

Drug

Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution.The patient will receive Methylene Blue bolus with a dose of 1 mg/kg (Ideal Body Weight) over 30 minutes,followed by 0.25mg/kg/h as a continuous infusion for 6 hours for 5 days or discontinution of norepinephrine or until ICU discharge, whichever occurred first.

Other names: MB

Placebo

Drug

An identical volume of 5% dextrose solution from the placebo drug bag will be administered to patients using the same protocol as intervention arm.

Other names: 5%GS

Primary outcomes

  1. Time to shock reversal

    Time frame: 90 days after randomization

    Time to shock reversal was defined as the time from randomization to shock reversal.Reversal of shock was defined as the maintenance of a systolic blood pressure of at least 90 mmHg without vasopressor support for at least 24 h.

Secondary outcomes

  1. 28-day mortality

    Time frame: 28 days after randomization

    All-cause mortality at day 28 after randomization

  2. 90-day mortality

    Time frame: 90 days after randomization

    All-cause mortality at day 90 after randomization

  3. ICU mortality

    Time frame: 90 days after randomization

    All-cause mortality at ICU discharge

  4. Hospital mortality

    Time frame: 90 days after randomization

    All-cause mortality at hospital discharge

Other outcomes

  1. ICU length of stay

    Time frame: 90 days after randomization

    Time in days until ICU discharge

  2. hospital length of stay

    Time frame: 90 days after randomization

    Time in days until hospital discharge

  3. ICU-free days up to day 28

    Time frame: 28 days after randomization

    Total number of days alive and free of ICU stay during the 28 days after randomization.

  4. vasopressor-free days up to day 28

    Time frame: 28 days after randomization

    Total number of days alive and free of vasopressor during the 28 days after randomization.

  5. ventilator support-free days up to day 28

    Time frame: 28 days after randomization

    Total number of days alive and free of ventilator support during the 28 days after randomization.

  6. CRRT-free days up to day 28

    Time frame: 28 days after randomization

    Total number of days alive and free of CRRT during the 28 days after randomization.

  7. 72h lactate

    Time frame: 72 hours after randomization

    lactate level at 72h after randomization

  8. 72h Delta SOFA

    Time frame: 72 hours after randomization

    Initial SOFA score at enrollment-SOFA score after 72 h;If the patient discharged within 72 h after being enrolled in the study, the SOFA score at discharge was used for the analysis.

  9. 72h P/F

    Time frame: 72 hours after randomization

    P/F at 72h after randomization

Sponsors and collaborators

Lead sponsor

Northern Jiangsu People's Hospital

Other

Registry information

Official study title

Initiation of Methylene Blue for Septic Shock in Adults: A Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 1, 2024
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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