Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

The goal of this clinical trial is to investigate whether methylene blue injection can safely and effectively improve the survival rate of patients with severe septic shock, shorten the duration of norepinephrine use, reduce the dosage of vasopressors, promptly correct hemodynamics, and improve tissue perfusion and organ function impairment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years.

Meets the Sepsis 3.0 criteria for septic shock: patients with infection who, despite adequate fluid resuscitation, require vasopressor therapy to maintain a mean arterial pressure (MAP) of ≥ 65 mmHg and have a blood lactate concentration > 2 mmol/L.

Diagnosed with septic shock and started on norepinephrine within 24 hours.

Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.

Disqualifiers

Pregnant or breastfeeding women.

Individuals allergic to methylene blue or any components of the methylene blue injection.

Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.

Patients with an expected survival time of less than 48 hours.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Methylene Blue Intervention Group

    Drug

    In addition to standard treatment, patients will receive methylene blue intervention. The method is as follows: a loading dose of 2.5 mg/kg administered via micro-pump over 15 minutes, followed by a continuous infusion at a rate of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first. If norepinephrine needs to be increased to 0.1 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.

  • Normal Saline Control Group

    Drug

    In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.

Treatment groups

488 Participants
are divided into 2 treatment groups
Group A: Methylene Blue Intervention GroupExperimental treatment 1 intervention
Group B: Normal Saline Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

28-day survival rate of enrolled patients

Our primary endpoint is the 28-day survival rate of enrolled patients: All enrolled patients will be followed from the time of randomization until 28 days post-enrollment, recording the survival status on the 28th day after enrollment. If a patient dies within 28 days post-enrollment, the number of survival days will be recorded. Note: 1. Cases where the family requests discharge to home for end-of-life care and the patient subsequently dies will be counted as death cases. 2. Cases where the family requests discharge for non-medical reasons such as financial constraints and no further treatment is sought will be counted as dropout cases.

Time frame
28-day

Secondary outcomes

1

The duration and dosage of norepinephrine use

The duration of norepinephrine use:The time from the start of norepinephrine (NE) administration after sepsis diagnosis until its discontinuation. The definition of discontinuation: NE must be stopped for ≥2 hours; if NE is stopped for \<2 hours, it is not considered discontinued. If NE is re-administered after being stopped for more than 2 hours, it is still considered discontinued. The dosage of norepinephrine use:the total dose of NE used within 72 hours after the patient is enrolled in the study.

Time frame
28-day
2

The duration of mechanical ventilation

The number of days without mechanical ventilation within 28 days post-enrollment. Note: Only full days without mechanical ventilation can be counted as one day.

Time frame
28-day
3

The duration of ICU stay

ICU length of stay: the number of days in the ICU starting from the time of patient enrollment in the study. Note: Some patients may have multiple ICU admissions; only the ICU stay duration after the current enrollment is recorded.

Time frame
28-day
4

The duration of overall hospital stay

The duration of overall hospital stay: the total number of days hospitalized starting from the time of patient enrollment in the study. Note: Days hospitalized prior to enrollment are not included.

Time frame
28-day

Other outcomes

Sponsors and contacts

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First Affiliated Hospital of Zhejiang University

Lead sponsor

Yuyao People's Hospital

Collaborator

Taizhou Enze Medical Center Group

Collaborator

Ningbo Medical Center Lihuili Hospital

Collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

Collaborator

The second Nanning People's Hospital

Collaborator

GUI LIN PEOPLE'S HOSPITAL

Collaborator

First Affiliated Hospital, Sun Yat-Sen University

Collaborator

The First People's Hospital of Huzhou

Collaborator

Hangzhou Yuhang District Second People's Hospital

Collaborator

Wuming Hospital of Guangxi Medical University

Collaborator