[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07633600":3,"trial-entities:NCT07633600":114,"trial-summary:NCT07633600":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":15,"eligibility_criteria":78,"std_ages":88,"locations":91,"central_contacts":101,"overall_officials":111,"references":112,"see_also_links":113},"NCT07633600","IRB Study 4762","Phenotype Guided Vasoactive Medication During Kidney Transplantation","Intraoperative Circulation Phenotyping to Guide Vasoactive Medication in Kidney Transplant Recipients","NOT_YET_RECRUITING","2027-12-01","2026-06","2026-06-08","2026-06-01","Jennifer Cutler","OTHER",false,"The goal of this clinical trial is to learn if vasopressin improves the body's response to intravenous fluids during kidney transplantation in patients who have relaxed blood vessels. Researchers will compare the results of vasopressin to those who received calcium chloride.","This prospective, single-arm interventional study evaluates a phenotype-guided vasoactive protocol during adult kidney transplantation. Intraoperative monitoring includes pulse contour analysis and repeated FPC testing. Based on predefined phenotype criteria, vasoactive support is assigned as follows: vasopressin infusion for Hyperdynamic physiology, norepinephrine infusion for Mixed Physiology, calcium chloride boluses and\u002For low-dose dopamine infusion for Poor Contractility, and fluid-guided management for Normal physiology.",[19,20],"Kidney Transplant","Fluid Management",[22,19],"Vasoactive Management","INTERVENTIONAL","PREVENTION",[26],"PHASE4",{"count":28,"type":29},255,"ESTIMATED",[31],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":37},"DRUG","Phenotype-Guided Vasoactive Management","Recipients undergo intraoperative circulation phenotyping using pulse contour monitoring and flow-pressure coupling testing. Vasoactive support is assigned according to phenotype: vasopressin infusion for Hyperdynamic physiology, norepinephrine infusion for Mixed Physiology, calcium chloride and\u002For low-dose dopamine for Poor Contractility, and fluid-guided support for Normal physiology.",[36],"Experimental: Phenotype-Guided Vasoactive Protocol",[38,39,40,41],"Norepinephrine","Calcium Chloride","Dopamine","Vasopressin",[43],{"measure":44,"description":45,"timeFrame":46},"Positive Flow-Pressure Coupling Proportion in Hyperdynamic Phenotype as measured by pulse contour analysis on the Edwards Hemosphere","Proportion of positive flow-pressure coupling responses among recipients classified intraoperatively as Hyperdynamic. Flow-Pressure coupling is defined as demonstrating both fluid responsiveness and pressure responsiveness following a fluid responsiveness test. Fluid responsiveness is defined as \\>= 10% increase in the stroke volume (ml\u002Fbeat) and pressure responsiveness is defined as \\>= 15% in the mean arterial pressure (mmHg) 2 minutes after conclusion of the fluid responsiveness test. Hyperdynamic phenotypes are defined as having the following hemodynamics: CI \\>4.0 L\u002Fmin\u002Fm², SVRI \\\u003C1970 dyn·s·cm-⁵\u002Fm², and dP\u002Fdt \\>1000 mmHg\u002Fs .","Intraoperative (from induction to end of surgery)",[48,52,55,59,62,65,68,71],{"measure":49,"description":50,"timeFrame":51},"Characterization of flow-pressure coupling in Normal, Mixed Physiology, and Poor-contractility phenotypes as measured with pulse contour analysis on the Edwards Hemosphere","Measurement of positive rate of FPC per FRT in all remaining circulatory phenotypes. These phenotypes are defined by the following hemodynamics: • Normal phenotype: CI 2.5-4.0 L\u002Fmin\u002Fm² and SVRI 1970-2390 dyn·s·cm-⁵\u002Fm² ; • Mixed physiology: CI 2.5-4.0 L\u002Fmin\u002Fm², SVRI \\\u003C1970 dyn·s·cm-⁵\u002Fm², and dP\u002Fdt \\\u003C1000 mmHg\u002Fs and • Poor Contractility: CI \\\u003C2.5 L\u002Fmin\u002Fm² and dP\u002Fdt \\\u003C1000 mmHg\u002Fs .","intraoperative",{"measure":53,"description":54,"timeFrame":51},"Analysis of intraoperative cardiac index (CI) measured with pulse contour analysis on the Edwards Hemosphere","recording of CI L\u002Fmin\u002Fm² as baseline, and after each FRT",{"measure":56,"description":57,"timeFrame":58},"Protocol Adherence","Proportion of intraoperative decision points consistent with the phenotype-guided protocol.","Intraoperative",{"measure":60,"description":61,"timeFrame":51},"Analysis of Intraoperative Systemic vascular resistance index (SVRI) measured with pulse contour analysis on the Edwards Hemosphere","Recording of SVRI dyn·s·cm-⁵\u002Fm² as baseline, and after each FRT",{"measure":63,"description":64,"timeFrame":51},"Analysis of Intraoperative mean arterial pressure (MAP) measured with pulse contour analysis on the Edwards Hemosphere","recording of MAP mmHg as baseline and after each FRT",{"measure":66,"description":67,"timeFrame":51},"Analysis of Intraoperative Contractility (dP\u002Fdt) measured with pulse contour analysis on the Edwards Hemosphere.","Recording of dP\u002Fdt mmHg\u002Fs as baseline and after each FRT",{"measure":69,"description":70,"timeFrame":51},"Analysis of Intraoperative EaDyn (PPV\u002FSVV) with pulse contour analysis on the Edwards Hemosphere","Recording of EaDyn (PPV\u002FSVV) as baseline and after each FRT",{"measure":72,"description":73,"timeFrame":74},"Recording of delayed graft function, defined as the need for dialysis within the first week following kidney transplantation","Delayed graft function will be recorded as yes or no","Postoperative day 0 to postoperative day 7","ALL","18 Years",null,{"inclusion":79,"exclusion":83,"raw_text":87},[80,81,82],"Adults aged 18 years or older","Undergoing kidney transplantation at Cedars-Sinai Medical Center","Able to provide informed consent",[84,85,86],"Patients unable to provide informed consent","Patients with contraindications to protocol vasoactive medications, as determined by the treating anesthesiologist","Patients in whom required intraoperative monitoring cannot be performed","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* Undergoing kidney transplantation at Cedars-Sinai Medical Center\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent\n* Patients with contraindications to protocol vasoactive medications, as determined by the treating anesthesiologist\n* Patients in whom required intraoperative monitoring cannot be performed",[89,90],"ADULT","OLDER_ADULT",[92],{"facility":93,"city":94,"state":95,"zip":96,"country":97,"geoPoint":98},"Cedars Sinai Medical Center","Los Angeles","California","90048","United States",{"lat":99,"lon":100},34.05223,-118.24368,[102,107],{"name":103,"role":104,"phone":105,"email":106},"Jennifer L Cutler, M.D.","CONTACT","310-497-4541","jennifer.cutler@cshs.org",{"name":108,"role":104,"phone":109,"email":110},"Leon Wang, M.D.","203-464-8236","leon.wang@cshs.org",[],[],[],{"nct_id":4,"conditions":115,"biomarkers":117},[116],"Kidney Transplantation",[],{"nct_id":4,"found":15,"summary":77,"prompt_version":77}]