[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629932":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":12,"centralContacts":24,"locations":30,"responsibleParty":44,"collaborators":12,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":12,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":12,"enrollmentInfo":57,"targetDuration":12,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":72,"whyStopped":12,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Assiut University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Standard Care (Control Group)","NO_INTERVENTION","Patients in this group will be managed according to the Surviving Sepsis Campaign (SSC) 2021 Guidelines",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Group B: Pmsf-Guided Resuscitation (Intervention Group).","ACTIVE_COMPARATOR","The Pmsf will be measured using the transient stop-flow arm cuff method. A pneumatic tourniquet cuff is placed on the upper arm. The cuff is inflated to a pressure 50 mmHg higher than the systolic arterial pressure for a duration of 60 seconds.\n\nThe invasive arterial pressure and the ipsilateral peripheral venous pressure are recorded.\n\nThree consecutive measurements are performed with a 5-minute interval. Measurement Technique (RRI): Renal Doppler will be performed using a convex probe. The inter-lobar arteries will be visualized, and RRI will be calculated.\n\nTherapeutic Algorithm:\n\nState 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume.\n\nState 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine.\n\nState 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics",[18],"Other: Hemodynamic measurements during reduction in Norepinephrine and fluid boli.",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"Hemodynamic measurements during reduction in Norepinephrine and fluid boli.","State 1: Low Gradient and Low Pmsf AND RRI ≤ 0.70: Absolute Hypovolemia. Administer fluid bolus (250-500 ml crystalloid) to recruit stressed volume.\n\nState 2: Low Gradient and High Pmsf AND RRI ≥ 0.70: Vasoplegia with relative hypovolemia. Initiate or increase Norepinephrine.\n\nState 3: Adequate Gradient but High RRI ≥0.70: Renal Congestion. Discontinue fluids immediately Consider administration of diuretics",[14],[25],{"name":26,"role":27,"phone":28,"phoneExt":12,"email":29},"Mark Wageh Debais, assistant lecturer","CONTACT","+201032090320","markwageh@aun.edu.eg",[31],{"facility":32,"status":12,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":12},"Assiut University Hospitals","Asyut","Asyut Governorate","71511","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.18368,27.18096,{"lat":42,"lon":41},{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Mark Wageh Debais","Assistant Lecturer","100629932","hemodynamic-resuscitation-guided-by-non-invasive-mean-systemic-filling-pressure-to-prevent-acute-kidney-injury-in-septic-shock-100629932",false,"NCT07481097","Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock","Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock: A Randomized Controlled Trial Integrating Renal Doppler Indices","Inclusion Criteria:\n\n* Adult patients (Age 18 years or older) admitted to the Intensive Care Unit.\n* Primary diagnosis of Septic Shock defined according to the Third International Consensus Definitions for Sepsis (Sepsis-3): Sepsis with persisting hypotension requiring vasopressors to maintain MAP 65 mmHg or greater and having a serum lactate level greater than 2 mmol\u002FL despite adequate volume resuscitation.\n* Patients must be mechanically ventilated and sedated to ensure baseline hemodynamic stability.\n* Presence of an invasive arterial catheter and a central venous catheter.\n\nExclusion Criteria:\n\n* Known pre-existing chronic kidney disease (CKD Stage 4 or 5) or patients on chronic renal replacement therapy.\n* Contraindications to arm cuff inflation, including upper limb trauma, -lymphedema, arteriovenous fistula, or peripheral vascular disease.\n* Severe valvular heart disease, specifically severe tricuspid regurgitation, which invalidates CVP interpretation.\n* Intra-abdominal hypertension (Intra-abdominal pressure greater than 15 mmHg) which mechanically alters venous return independent of blood volume.\n* Moribund patients with a predicted mortality within 24 hours.","ALL","18 Years",{"count":58,"type":59},100,"ESTIMATED","INTERVENTIONAL",[62],"NA","The goal of this clinical trial is to evaluate the efficacy of a hemodynamic resuscitation protocol guided by the Venous Return Gradient (Pmsf - CVP), measured via the non-invasive arm cuff technique, in reducing the incidence of Acute Kidney Injury (AKI) in patients with septic shock compared to standard care and to assess the precision and reproducibility of the non-invasive arm cuff Pmsf measurement in the septic shock population and to determine the correlation between the systemic Venous Return Gradient and the renal micro-circulatory Resistance Index (RRI).",[65],"Acute Kidney Injury Due to Sepsis",[67,68,69,70,71],"sepsis","acute kidney injury","resuscitation","mean systemic filling pressure","renal resistive index","NOT_YET_RECRUITING","2026-03-15",{"date":75,"type":76},"2026-03-18","ACTUAL",{"date":78,"type":59},"2026-04-01",{"date":80,"type":59},"2028-08",{"name":5,"class":6},1]