[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"carotid-artery-elasticity-alterations\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:carotid-artery-elasticity-alterations":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100586448","phase-4-shenfu-injection-modulates-carotid-elasticity-in-septic-shock-100586448",false,"NCT06915506","Shenfu Injection Modulates Carotid Elasticity in Septic Shock","The Effect of Shenfu Injection on Carotid Artery Elasticity in Septic Shock Patients: A Prospective Observational Pilot Study","Inclusion Criteria\n\n* Age ≥ 18 years.\n* Diagnosis of sepsis or septic shock in the acute phase, as defined by the -Sepsis-3 criteria (confirmed infection with Sequential Organ Failure Assessment \\[SOFA\\] score ≥ 2 points above baseline).\n* Voluntary participation with written informed consent provided by the patient or legally authorized representative.\n\nExclusion Criteria\n\n* Severe carotid atherosclerosis (e.g., carotid Intima-Media Thickness (IMT)\\>1.2 mm or confirmed plaque formation) diagnosed by prior imaging.\n* Significant cardiovascular comorbidities that may confound hemodynamic assessments, including:\n* Severe cardiomyopathy (e.g., ejection fraction \\\u003C30%).\n* Uncontrolled arrhythmias (e.g., ventricular tachycardia, atrial fibrillation with rapid ventricular response).\n* Congenital heart disease with hemodynamic instability.\n* Active hepatic or renal insufficiency (e.g., Child-Pugh class C, dialysis dependence) or advanced systemic diseases (e.g., metastatic malignancy, terminal illness).\n* Poor ultrasound image quality precluding reliable speckle tracking analysis (e.g., inadequate acoustic window, motion artifacts).\n* Pregnancy or lactation (due to potential hormonal influences on vascular physiology).\n* Withdrawal from the study or inability to complete follow-up assessments (e.g., non-compliance, transfer to another facility).","ALL","18 Years","75 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","What is this study about? We are studying whether Shenfu Injection (a traditional Chinese herbal medicine) can help improve blood vessel health in patients with septic shock-a severe complication of infections that can damage blood vessels and organs. Specifically, we want to see if this treatment makes the carotid artery (a major neck blood vessel) more flexible and resilient, which may support recovery.\n\nWho can join? Adults (18 years or older) diagnosed with septic shock by their doctors. Patients whose doctors plan to use Shenfu Injection as part of their treatment. Patients who agree to participate and sign a consent form. Who cannot join? Patients with severe heart conditions, advanced organ failure, or major neck artery disease.\n\nPregnant or breastfeeding women. Those unable to complete the study procedures. What will happen during the study?\n\nSafe and Pain-Free Tests:\n\nUltrasound scans: A non-invasive imaging method will be used to measure the flexibility and blood flow of your neck artery.\n\nAdvanced imaging technology: A special ultrasound technique (called speckle tracking) will take detailed pictures of your artery's movement during heartbeat cycles.\n\nTiming of Tests:\n\nScans will be done before receiving Shenfu Injection and 1, 2, 3 hours after the injection, plus 1 hour after treatment ends.\n\nOther Data Collection:\n\nBlood tests to check inflammation and organ function. Recording your health status (e.g., blood pressure, heart rate) and recovery progress (e.g., time in the Intensive Care Unit (ICU), survival rates).\n\nWhat are the benefits and risks? Benefits: This study may help doctors better understand how Shenfu Injection works and improve future care for septic shock patients.\n\nRisks: The ultrasound scans are routine, safe, and painless. There is no extra risk beyond standard hospital care.\n\nYour Rights and Safety Voluntary Participation: You can withdraw at any time without affecting your treatment.\n\nEthical Approval: This study is reviewed and approved by the hospital's ethics committee.\n\nPrivacy: Your personal information and test results will be kept confidential.",[27,28,29,30,31],"Septic Shock","Vascular Dysfunction","Arterial Stiffness","Carotid Artery Elasticity Alterations","Sepsis",[33,34,35,36,37,38,39,40,41,42],"Septic shock","Shenfu Injection","Carotid artery elasticity","Ultrasound speckle tracking","Vascular dysfunction","Arterial stiffness","Strain imaging","Traditional Chinese Medicine (TCM)","Circumferential strain (CS)","Sepsis-associated vascular injury","NOT_YET_RECRUITING","2025-04-04",{"date":46,"type":47},"2025-04-08","ACTUAL",{"date":49,"type":21},"2025-04-15",{"date":51,"type":21},"2026-04-30",{"name":53,"class":54},"First Affiliated Hospital of Wannan Medical College","OTHER"]