[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638043":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":20,"locations":21,"responsibleParty":40,"collaborators":20,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":20,"eligibilityCriteria":50,"healthyVolunteers":46,"sex":51,"minAge":52,"maxAge":20,"enrollmentInfo":53,"targetDuration":20,"studyType":56,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":67,"whyStopped":20,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},{"fullName":5,"class":6},"First Affiliated Hospital of Wannan Medical College","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Shenfu Injection Group","EXPERIMENTAL","All enrolled patients with septic shock will receive a single intravenous infusion of Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.).\n\nThe drug dose is 100 mL, diluted in 250 mL of normal saline, infused over 1 hour after initial hemodynamic stabilization.\n\nHemodynamic and microcirculatory parameters are measured before infusion and 3 hours after infusion, including vascular waterfall difference (critical closure pressure minus mean systemic filling pressure) and related physiological variables.\n\nNo control or placebo arm is included in this study.",[13],"Drug: Shenfu Injection",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Shenfu Injection","All participants in the study will receive a single intravenous infusion of Shenfu Injection, a traditional Chinese medicine produced by China Resources Sanjiu Pharmaceutical Co., Ltd. The injection contains extracts of Ginseng Radix et Rhizoma and Aconiti Lateralis Radix Praeparata.\n\nEach dose consists of 100 mL Shenfu Injection, diluted in 250 mL normal saline, and administered through continuous intravenous infusion over 1 hour after initial hemodynamic stabilization according to Surviving Sepsis Campaign guidelines.\n\nHemodynamic measurements will be performed before infusion (within 30 minutes) and at 3 hours after infusion. Variables include critical closure pressure (Pcc), mean systemic filling pressure (Pmsf), cardiac index, systemic vascular resistance, central venous oxygen saturation, arterial-venous CO₂ difference, and blood lactate concentration.\n\nNo other investigational drugs, placebos, or control interventions are administered in this study.",[9],null,[22],{"facility":23,"status":20,"city":24,"state":25,"zip":26,"country":27,"countryCode":28,"cosmosGeoPoint":29,"geoPoint":34,"contacts":35},"The First Affiliated Hospital of Wannan Medical College (Yijishan Hospital of Wannan Medical College)","Wuhu","Anhui","241001","China","CN",{"type":30,"coordinates":31},"Point",[32,33],118.42947,31.35259,{"lat":33,"lon":32},[36],{"name":37,"role":38,"phone":20,"phoneExt":20,"email":39},"qiancheng xu, PhD","CONTACT","xu19871011@163.com",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Qiancheng Xu","Principal Investigator","100638043","effect-of-shenfu-injection-on-the-vascular-waterfall-phenomenon-in-patients-with-septic-shock-100638043",false,"NCT07603024","Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock","Effect of Shenfu Injection on the Vascular Waterfall Phenomenon in Patients With Septic Shock: A Prospective Pilot Study","nclusion Criteria Septic shock diagnosed according to Sepsis-3 criteria after adequate fluid resuscitation.\n\nAge ≥ 18 years. Within 24 hours of ICU admission. Receiving norepinephrine ≥ 0.10 µg\u002Fkg\u002Fmin to maintain mean arterial pressure ≥ 65 mmHg.\n\nHemodynamically stable without vasopressor dose adjustment for ≥ 30 minutes before baseline measurement.\n\nEndotracheal intubation with controlled mechanical ventilation under continuous sedation and analgesia.\n\nPresence of both arterial and central venous catheters with PiCCO monitoring capability.\n\nWritten informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria Cardiogenic shock as primary diagnosis or cardiac index \\\u003C 2.2 L\u002Fmin\u002Fm² after optimization.\n\nSevere pulmonary bullae, pneumothorax, or conditions precluding safe inspiratory hold maneuvers.\n\nPregnancy or lactation. Expected ICU stay \\\u003C 48 hours or limitation of life-sustaining therapy. Known allergy or contraindication to Shenfu Injection or its ingredients (e.g., ginseng, aconitum).","ALL","18 Years",{"count":54,"type":55},20,"ESTIMATED","INTERVENTIONAL",[58],"NA","This prospective single-center clinical trial aims to evaluate the circulatory and microcirculatory effects of Shenfu Injection in patients with septic shock. The study focuses on the vascular waterfall phenomenon, which describes the relationship between arterial and venous pressures in the microcirculation.\n\nEligible participants with septic shock will receive an intravenous infusion of 100 mL Shenfu Injection (manufactured by China Resources Sanjiu Pharmaceutical Co., Ltd.). Hemodynamic and oxygen metabolism parameters will be measured before and 3 hours after treatment. The main goal is to determine whether Shenfu Injection influences the vascular waterfall difference, expressed as the gap between critical closure pressure and mean systemic filling pressure.\n\nThis study will also record changes in cardiac index, systemic vascular resistance, blood lactate, venous oxygen saturation, and norepinephrine requirement. Findings will provide preliminary clinical evidence about the role of Shenfu Injection in circulatory regulation during septic shock and help design future randomized controlled studies.",[61],"Septic Shock",[17,63,61,64,65,66],"Traditional Chinese Medicine","Vascular Waterfall Phenomenon","Critical Closure Pressure","Intensive Care Unit","NOT_YET_RECRUITING","2026-05-18",{"date":70,"type":71},"2026-05-22","ACTUAL",{"date":73,"type":55},"2026-07-01",{"date":75,"type":55},"2027-06-30",{"name":5,"class":6},1]