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Efficacy and Safety of Methylene Blue in Severe Septic Shock: A Prospective Randomized Controlled Trial

Efficacy and Safety of Methylene Blue in Severe Septic Shock: A Prospective Randomized Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115563
Enrollment
Unknown
Registered
2025-12-29
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Septic Shock

Interventions

Methylene blue intervention group:Use methylene blue
Saline placebo group:Use saline solution

Sponsors

Ningbo Beilun People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Over 18 years old; 2. Meets the diagnostic criteria for septic shock as defined in sepsis 3.0; 3. Diagnosed with septic shock and started on norepinephrine within 24 hours; 4. The dosage of norepinephrine required to maintain a mean arterial pressure of >=65 mmHg is >=0.5 µg/kg/min.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Expected survival time < 48 hours; 3. Noradrenaline has been used for more than 24 hours; 4. Patients with concurrent cardiogenic, obstructive, or hypovolemic shock; 5. Individuals allergic to methylene blue components; 6. Patients with glucose-6-phosphate dehydrogenase deficiency; 7. In the past three days, individuals who have suffered from methemoglobinemia or acute cyanide poisoning caused by chemicals such as nitrite, nitrate, aniline, nitrobenzene, trinitrotoluene, benzoquinone, phenylhydrazine, and drugs containing or producing aromatic amines (such as acetanilide, acetaminophen, phenacetin, benzocaine, etc.); 8.The patient or their representative refuses to participate; 9. During the research process, patients who voluntarily discharged themselves, transferred to other hospitals, gave up treatment, or experienced adverse drug reactions, rendering the trial unable to continue; 10. Those with missing clinical data and information.

Design outcomes

Primary

MeasureTime frame
28-day all-cause mortality after diagnosis of septic shock;

Secondary

MeasureTime frame
Duration of norepinephrine administration after diagnosis of septic shock;Mechanical ventilation duration;Total dose of norepinephrine used;CRRT treatment rate;ICU length of stay;The duration of not using norepinephrine within 28 days;total hospital stay;

Countries

China

Contacts

Public ContactHuang Zhiping

Ningbo Beilun People’s Hospital

hnhzhp@sina.com+86 574 8687 6536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026