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Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled 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.
Researchers will compare methylene blue to a placebo (a look-alike substance that contains no drug) to see if methylene blue works to treat severe septic shock. 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).
Age
All ages
Sex
ALL
Healthy Volunteers
No
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Start Date
June 22, 2024
Primary Completion Date
June 20, 2026
Completion Date
June 20, 2026
Last Updated
December 30, 2024
488
ESTIMATED participants
Methylene Blue Intervention Group
DRUG
Normal Saline Control Group
DRUG
Lead Sponsor
First Affiliated Hospital of Zhejiang University
Collaborators
NCT04850456
NCT04955210
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05267821