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Early use of methylene blue for reducing organ dysfunction in severe burn patients: a multicenter, open-label, adaptive randomized controlled trial

Early use of methylene blue for reducing organ dysfunction in severe burn patients: a multicenter, open-label, adaptive randomized controlled trial (BLUE)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097204
Enrollment
Unknown
Registered
2025-02-14
Start date
2025-02-16
Completion date
Unknown
Last updated
2025-02-17

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

Conditions

Burns, Burn shock, organ dysfunction after burns

Interventions

Methylene blue plus standard care group:Methylene blue is infused intravenously at a bolus of of 2 mg/kg, and then maintained at 0.25 mg/kg/h until 72h after burns
Standard care group:Fluid resuscitation was carried out according to the formula of the Third Military Medical University.

Sponsors

The First Affiliated Hospital of Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Provision of signed and dated informed consent form; 2.Flame burns and scald burns; 3.Aging 18-65 years; 4.Burn patients with 30% or greater of total body surface area (TBSA) burn and equal to or less than 80% TBSA burn; 5.Admitted earlier than 12h after burns; 6.Anticipated hospital stay: 7 days or more;

Exclusion criteria

Exclusion criteria: 1.Known allergic reactions to components of the methylene blue, phenothiazines, food dyes; 2.Pregnancy or lactation; 3.Deficiency of G6PD gene or family history; 4.Exposure to 5-HT inhibitors in the past 4 weeks; 5.Predicted death in 72h; 6.Severe inhalation injury; 7.Chronic kidney/ liver dysfunction, lung infection and other severe basic conditions; 8.Tumor;

Design outcomes

Secondary

MeasureTime frame
Organ dysfunction days;All-cause mortality;?mSOFA7;Incidence of POD;Coefficient of the fluid resuscitation during burn shock;Amount of vasoactive agents during burn shock;lactate clearance rate;Wound healing time per burn index;Inflammation and stress levels;Nitric oxide signaling levels;Quality of life;Incidence of adverse event;

Primary

MeasureTime frame
Incidence of new-onset / worsening organ dysfunction between randomization and 7 days after burns.;

Countries

China

Contacts

Public ContactGaoxing Luo

The First Affiliated Hospital of Army Medical University

gaoxing.luo@burnstrauma.com+86 23 68765941

Outcome results

None listed

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