Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
NCT ID: NCT06481410
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
488 participants
INTERVENTIONAL
2024-06-22
2026-06-20
Brief Summary
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Detailed Description
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Participants will:
Administer a loading dose of 2.5 mg/kg via micro-pump over 15 minutes, followed by a maintenance 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 0.25 μg/kg/min before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.
Primary Study Endpoint
\- 28-day all-cause mortality rate starting from the diagnosis of septic shock.
Secondary Study Endpoints
* Time from the start to the discontinuation of norepinephrine after the diagnosis of septic shock.
* Total dose of norepinephrine used (from enrollment to 72 hours).
* Number of days without norepinephrine within 28 days.
* Duration of mechanical ventilation.
* Rate of CRRT (Continuous Renal Replacement Therapy).
* Length of ICU stay.
* Total hospital stay.
Record the following indicators before methylene blue intervention and at 24 hours, 72 hours, and 5 days after the intervention:
* Highest serum lactate level.
* Lowest mean arterial pressure.
* Alanine aminotransferase (ALT).
* Total bilirubin.
* Creatinine.
* Oxygenation index (P/F ratio).
* Creatine kinase-MB (CK-MB).
* Troponin I (TNI).
* Systemic vascular resistance index (SVRI).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Methylene Blue Intervention Group
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.
Methylene Blue Intervention Group
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
Normal saline solution, administered in the same manner and duration as the methylene blue intervention.
Normal Saline Control Group
In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.
Interventions
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Methylene Blue Intervention Group
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
In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Diagnosed with septic shock and started on norepinephrine within 24 hours.
4. Requires a norepinephrine dose of ≥ 0.1 μg/kg/min to maintain a MAP of ≥ 65 mmHg.
Exclusion Criteria
2. Individuals allergic to methylene blue or any components of the methylene blue injection.
3. Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.
4. Patients with an expected survival time of less than 48 hours.
5. Patients who have been on norepinephrine for more than 24 hours.
ALL
No
Sponsors
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Yuyao People's Hospital
OTHER
Taizhou Enze Medical Center Group
OTHER
NINGBO MEDICAL CENTER LIHUIIHOSPITAI
UNKNOWN
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
The second Nanning People's Hospital
UNKNOWN
GUI LIN PEOPLE'S HOSPITAL
UNKNOWN
Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University
UNKNOWN
The First People's Hospital of Huzhou
OTHER
Hangzhou Yuhang District Second People's Hospital
UNKNOWN
Wuming Hospital of Guangxi Medical University
UNKNOWN
First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Wenqiao Yu, PhD
Role: primary
Other Identifiers
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2024-051
Identifier Type: -
Identifier Source: org_study_id