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

NCT06481410 | Recruiting

• 1 other identifier: 2024-051
• Study Type: interventional
• Target: 488
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Septic Shock; Methylene Blue; Sepsis

Keywords

Septic Shock; Methylene blue; Sepsis

Outcome Measures

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.

  28-day

Secondary Outcomes (5)

• The duration and dosage of norepinephrine use

  28-day

• The duration of mechanical ventilation

  28-day

• The duration of ICU stay

  28-day

• The duration of overall hospital stay

  28-day

• The safety of methylene blue injection

  28-day

Study Arms (2)

Methylene Blue Intervention Group

EXPERIMENTAL

Methylene blue injection, 2.5 mg/kg loading dose over 15 minutes, followed by a continuous infusion of 0.25 mg/kg/hour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first.

Drug: Methylene Blue Intervention Group

Normal Saline Control Group

PLACEBO COMPARATOR

Normal saline solution, administered in the same manner and duration as the methylene blue intervention.

Drug: Normal Saline Control Group

Interventions

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.

Methylene Blue Intervention Group

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.

Normal Saline Control Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who have been on norepinephrine for more than 24 hours.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead
• Yuyao People's Hospital: collaborator
• Taizhou Enze Medical Center Group: collaborator
• NINGBO MEDICAL CENTER LIHUIIHOSPITAI: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• The second Nanning People's Hospital: collaborator
• GUI LIN PEOPLE'S HOSPITAL: collaborator
• Guangxi Hospital Division of The 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

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Shock, Septic; Sepsis

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Wenqiao Yu, PhD

CONTACT

+86-18868787588; yuwenqiao1980@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study implements blinding for the outcome assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, randomized, controlled, single-blind study.

Study Record Dates

• First Submitted: June 21, 2024
• First Posted: July 1, 2024
• Study Start: June 22, 2024
• Primary Completion (Estimated): June 20, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: December 30, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)