[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641345":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":58,"collaborators":62,"id":64,"slug":20,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":20,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":85,"overallStatus":95,"whyStopped":20,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Papaverine Group","EXPERIMENTAL","Adult patients with septic shock receiving norepinephrine support and PiCCO-based hemodynamic monitoring will receive intravenous papaverine. Papaverine will be administered as 30 mg over 10 minutes, followed by continuous infusion at 2-5 mg\u002Fhour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamics, macrocirculatory parameters, tissue perfusion variables, vasopressor requirement, and safety outcomes will be assessed before and after papaverine administration.",[13],"Drug: Papaverine",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Papaverine","Papaverine will be administered intravenously as 30 mg infused over 10 minutes, followed by continuous infusion at 2-5 mg\u002Fhour. The maintenance infusion rate may be adjusted according to the patient's hemodynamic status, mean arterial pressure, heart rate, vasopressor requirement, PiCCO-derived variables, and adverse events. Dose reduction, temporary interruption, or discontinuation of papaverine is permitted for safety reasons, including clinically significant hypotension, rapidly increasing vasopressor requirement, new-onset or worsening arrhythmia, myocardial ischemia, severe liver function abnormality, or any other clinically significant adverse event judged by the treating physician or investigator.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"qiancheng xu, PhD","CONTACT","+86-18297529106","qianchengxu@wnmc.edu.cn",[28,46],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"The First Affiliated Hospital of Bengbu Medical University","Bengbu","Anhui","233000","China","CN",{"type":36,"coordinates":37},"Point",[38,39],117.36083,32.94083,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Cheng Liu, PhD","+86-18109657129","3117999213@qq.com",{"facility":47,"status":20,"city":48,"state":31,"zip":49,"country":33,"countryCode":34,"cosmosGeoPoint":50,"geoPoint":54,"contacts":55},"The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)","Wuhu","241000",{"type":36,"coordinates":51},[52,53],118.42947,31.35259,{"lat":53,"lon":52},[56],{"name":57,"role":24,"phone":25,"phoneExt":20,"email":26},"qiancheng xu",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Qiancheng Xu","Principal Investigator",[63],{"name":29,"class":6},"100641345",false,"NCT07657741","Papaverine and Sublingual Microcirculation in Septic Shock","Effects of Papaverine on Sublingual Microcirculation and Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective, Multicenter, Single-arm, Open-label, Pilot Physiological Study","Inclusion Criteria:\n\n* Age 18-85 years.\n* Septic shock according to Sepsis-3 criteria, defined as suspected or documented infection requiring vasopressors to maintain mean arterial pressure ≥65 mmHg and serum lactate \\>2 mmol\u002FL after adequate fluid resuscitation.\n* Enrollment within 24 hours after diagnosis of septic shock in the ICU.\n* Receiving continuous norepinephrine infusion at enrollment.\n* Receiving invasive mechanical ventilation at enrollment, allowing assessment of vascular waterfall-related hemodynamic variables.\n* PiCCO-based hemodynamic monitoring, invasive arterial pressure monitoring, and central venous access available before papaverine administration.\n* Ability to obtain sublingual microcirculatory images of acceptable quality at baseline.\n* Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n* Shock primarily caused by non-septic etiologies, including cardiogenic, hypovolemic, obstructive, hemorrhagic, or anaphylactic shock.\n* Expected death or planned withdrawal of life-sustaining treatment within 24 hours.\n* Known allergy or hypersensitivity to papaverine.\n* Severe hemodynamic instability judged unsuitable for papaverine by the treating physician, including refractory hypotension or rapidly escalating vasopressor requirement.\n* Clinically significant arrhythmia, high-grade atrioventricular block, acute coronary syndrome, or active myocardial ischemia before enrollment.\n* Severe hepatic dysfunction judged by the investigator to substantially increase the risk of papaverine-related adverse effects.\n* Conditions preventing reliable sublingual microcirculatory assessment, including major oral or sublingual lesions, active oral bleeding, inability to access the sublingual area, or poor baseline image quality.\n* Pregnancy or lactation.\n* Participation in another interventional clinical trial that may affect study outcomes or safety.","ALL","18 Years","85 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"NA","This is a prospective, multicenter, single-arm, open-label, pilot physiological study designed to evaluate the effects of intravenous papaverine on sublingual microcirculation and the vascular waterfall phenomenon in adult patients with septic shock.\n\nEligible patients will have septic shock according to Sepsis-3 criteria, require norepinephrine support after adequate fluid resuscitation, and have PiCCO-based hemodynamic monitoring available before papaverine administration. Papaverine will be administered as an intravenous infusion of 30 mg over 10 minutes, followed by a continuous infusion of 2-5 mg\u002Fhour. Sublingual microcirculatory variables, vascular-waterfall-related indices, PiCCO-derived hemodynamic variables, macrocirculatory parameters, tissue perfusion variables, vasopressor dose, and safety outcomes will be assessed before and after papaverine administration.\n\nThe study aims to explore whether papaverine can improve microvascular perfusion and reduce microcirculatory flow impairment in septic shock, and to provide preliminary physiological and safety data for future controlled trials.",[81,82,83,84],"Septic Shock","Microcirculatory Dysfunction","Sublingual Microcirculation","Hemodynamic Instability",[86,17,87,88,89,90,91,92,93,94],"Septic shock","Sublingual microcirculation","Microcirculatory dysfunction","Vascular waterfall phenomenon","Critical closing pressure","Perfused vessel density","Microvascular flow index","Proportion of perfused vessels","Pilot physiological study","NOT_YET_RECRUITING","2026-06-14",{"date":98,"type":99},"2026-06-18","ACTUAL",{"date":101,"type":75},"2026-08-01",{"date":103,"type":75},"2027-12-30",{"name":5,"class":6},2]