Methylene Blue for the Treatment of Septic Shock

Northern Jiangsu People's Hospital

Status and phase: Enrolling; Phase 3

Conditions: Septic Shock

Treatments: Drug: Methylene Blue; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06532240

2024ky202

Details and patient eligibility

About

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

Full description

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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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76 participants in 2 patient groups, including a placebo group

Methylene Blue

Experimental group

Description:

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).

Treatment:

Drug: Methylene Blue

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo