Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock
NCT Number: NCT06481410
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Septic Shock|Methylene Blue|Sepsis
Interventions: DRUG: Methylene Blue Intervention Group|DRUG: Normal Saline Control Group
Sponsor: First Affiliated Hospital of Zhejiang University
Collaborators: Yuyao People's Hospital of Zhejiang Province|ENZE HOSPITAL OF TAIZHOU ENZE MEDICAL CENTER|NINGBO MEDICAL CENTER LIHUIIHOSPITAI|People's Hospital of Guangxi|The second Nanning People's Hospital|GUI LIN PEOPLE'S HOSPITAL|Guangxi Hospital Division of The First Affiliated Hospital, Sun Yat-sen University|The First People's Hospital of Huzhou|Hangzhou Yuhang District Second People's Hospital|Wuming Hospital of Guangxi Medical University
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 488
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06-20
Completion Date: 2026-06-20

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.

Primary Outcome Measures: 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 Outcome Measures: 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., 28-day|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., 28-day|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., 28-day|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., 28-day|The safety of methylene blue injection, We will record the complications due to the use of methylene blue, such as hemolysis: We will determine the presence of hemolysis by daily monitoring of urine color, red blood cells, hemoglobin count in complete blood count, and bilirubin levels in liver function tests. If the patient's urine turns dark brown (similar to soy sauce), accompanied by a decrease in hemoglobin and red blood cell count and a simultaneous increase in bilirubin, hemolysis will be considered., 28-day