[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100553078":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":53,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":25,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":25,"maxAge":25,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"First Affiliated Hospital of Zhejiang University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Methylene Blue Intervention Group","EXPERIMENTAL","Methylene blue injection, 2.5 mg\u002Fkg loading dose over 15 minutes, followed by a continuous infusion of 0.25 mg\u002Fkg\u002Fhour for 12 hours or until norepinephrine has been continuously discontinued for 4 hours, whichever comes first.",[13],"Drug: Methylene Blue Intervention Group",{"label":15,"type":16,"description":17,"interventionNames":18},"Normal Saline Control Group","PLACEBO_COMPARATOR","Normal saline solution, administered in the same manner and duration as the methylene blue intervention.",[19],"Drug: Normal Saline Control Group",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","In addition to standard treatment, patients will receive methylene blue intervention. The method is as follows: a loading dose of 2.5 mg\u002Fkg administered via micro-pump over 15 minutes, followed by a continuous infusion at a rate of 0.25 mg\u002Fkg\u002Fhour 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\u002Fkg\u002Fmin before the 12-hour period ends, continue using methylene blue until the 12-hour infusion is completed.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"In addition to standard treatment, patients will receive a placebo control with normal saline, administered for the same duration as the intervention group.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":25,"email":34},"Wenqiao Yu, PhD","CONTACT","+86-18868787588","yuwenqiao1980@zju.edu.cn",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":25,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"The First Affiliated Hospital, Zhejiang University School of Medicine","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":44,"coordinates":45},"Point",[46,47],120.16142,30.29365,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":52,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[54,56,58,61,63,66,68,70,72,74],{"name":55,"class":6},"Yuyao People's Hospital",{"name":57,"class":6},"Taizhou Enze Medical Center Group",{"name":59,"class":60},"Ningbo Medical Center Lihuili Hospital","OTHER_GOV",{"name":62,"class":6},"People's Hospital of Guangxi Zhuang Autonomous Region",{"name":64,"class":65},"The second Nanning People's Hospital","UNKNOWN",{"name":67,"class":65},"GUI LIN PEOPLE'S HOSPITAL",{"name":69,"class":6},"First Affiliated Hospital, Sun Yat-Sen University",{"name":71,"class":6},"The First People's Hospital of Huzhou",{"name":73,"class":65},"Hangzhou Yuhang District Second People's Hospital",{"name":75,"class":65},"Wuming Hospital of Guangxi Medical University","100553078","efficacy-and-safety-of-methylene-blue-in-the-treatment-of-severe-septic-shock-100553078",false,"NCT06481410","Efficacy and Safety of Methylene Blue in the Treatment of Severe Septic Shock","Exploratory Study on the Efficacy and Safety of Methylene Blue in Treating Severe Septic Shock Patients: A Prospective, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. 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\u002FL.\n3. Diagnosed with septic shock and started on norepinephrine within 24 hours.\n4. Requires a norepinephrine dose of ≥ 0.1 μg\u002Fkg\u002Fmin to maintain a MAP of ≥ 65 mmHg.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women.\n2. Individuals allergic to methylene blue or any components of the methylene blue injection.\n3. Individuals with a personal or family history of glucose-6-phosphate dehydrogenase (G6PD) deficiency.\n4. Patients with an expected survival time of less than 48 hours.\n5. Patients who have been on norepinephrine for more than 24 hours.","ALL",{"count":85,"type":86},488,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.",[92,93,94],"Septic Shock","Methylene Blue","Sepsis",[92,96,94],"Methylene blue","2024-12-26",{"date":99,"type":100},"2024-12-30","ACTUAL",{"date":102,"type":100},"2024-06-22",{"date":104,"type":86},"2026-06-20",{"name":5,"class":6},1]