Methylene Blue for the Treatment of Septic Shock

NCT06532240 | Completed Phase 3

• 1 other identifier: 2024ky202
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Keywords

septic shock; methylene blue; mortality

Outcome Measures

Primary Outcomes (1)

• Time to shock reversal

  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.

  90 days after randomization

Secondary Outcomes (4)

• 28-day mortality

  28 days after randomization

• 90-day mortality

  90 days after randomization

• ICU mortality

  90 days after randomization

• Hospital mortality

  90 days after randomization

Other Outcomes (9)

• ICU length of stay

  90 days after randomization

• hospital length of stay

  90 days after randomization

• ICU-free days up to day 28

  28 days after randomization

Study Arms (2)

Methylene Blue

EXPERIMENTAL

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).

Drug: Methylene Blue

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

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.

Also known as: MB

Methylene Blue

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.

Also known as: 5%GS

Placebo

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northern Jiangsu People's Hospital: lead

Study Sites (1)

Northern Jiangsu people's hospital

Yangzhou, Jiangsu, 225000, China

Location

MeSH Terms

Conditions

Shock, Septic

Interventions

Methylene Blue

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Phenothiazines; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Qingquan Lyu, Master

  Northern Jiangsu People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: August 5, 2024
• Primary Completion: October 24, 2025
• Study Completion: October 24, 2025
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)