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Trial · Interventional

CompletedPhase 3Registry data

Methylene Blue for the Treatment of Septic Shock

NCTNCT06532240 (opens ClinicalTrials.gov in a new tab)Other id2024ky202
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Overview

Status
Completed
Phase
Phase 3
Enrollment
88 participants (actual)
Sponsor
Northern Jiangsu People's Hospital · Other
Design
Randomized · Quadruple masking
Countries
1 country

China

Start
5 Aug 2024
Primary completion
24 Oct 2025
Completion
24 Oct 2025
First posted
1 Aug 2024
Last update posted
4 Feb 2026
Conditions
Septic Shock

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 3

    Methylene Blue for the Treatment of Septic Shock

    NCT06532240

    5 Aug 2024 to 24 Oct 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Methylene BlueDrug
  • PlaceboDrug

Arms2

  • Experimental

    Methylene Blue

    Methylene Blue 100mg will be diluted in 40ml 5% dextrose solution. Methylene Blue(1 mg/kg/IBW iv over 30min+0.25mg/kg/h x 6h) x 5-days/ discontinution of norepinephrine /ICU discharge (whichever occurred first).

  • Placebo comparator

    Placebo

    5% dextrose solution in a volume to match experimental arm component.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Time to shock reversal

    Time frame · 90 days after randomization

    Registry description

    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(4)

  1. 28-day mortality

    Time frame · 28 days after randomization

    Registry description

    All-cause mortality at day 28 after randomization

  2. 90-day mortality

    Time frame · 90 days after randomization

    Registry description

    All-cause mortality at day 90 after randomization

  3. ICU mortality

    Time frame · 90 days after randomization

    Registry description

    All-cause mortality at ICU discharge

  4. Hospital mortality

    Time frame · 90 days after randomization

    Registry description

    All-cause mortality at hospital discharge

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 90 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. age 18 years old or older; 2. diagnosis of septic shock within 12 h. 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 (as determined by the enrolling physician); 7. refusal of the attending staff or patient family; 8. participated in other study.

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