[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658873":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":38,"studyPopulation":39,"armGroups":40,"interventions":46,"overallOfficials":51,"centralContacts":56,"locations":65,"responsibleParty":85,"collaborators":28,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":100,"studyType":101,"phases":28,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":68,"whyStopped":28,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Pontificia Universidad Catolica de Chile","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":28},[9],{"measure":10,"description":11,"timeFrame":12},"To evaluate the occurrence of a significant radial-to-aortic (R-Ao) pressure gradient during the immediate post-cardiopulmonary bypass (CPB) period","A significant radial-to-aortic (R-Ao) pressure gradient is defined as a \\>20% difference in SBP or \\>10% difference in MAP sustained for \\>5 minutes) during the immediate post-cardiopulmonary bypass (CPB) period","within 15 minutes from the weaning of the CBP",[14,18,22,26,30,32],{"measure":15,"description":16,"timeFrame":17},"To determine the incidence of the R-Ao gradient in pediatric patients undergoing cardiac surgery with CPB and compare it with reported rates in the adult literature.","R-Ao Gradient Incidence: percentage of positive finding to the total of recruited patients in the study.\n\nReported Rates in adult population: As per an exhaustive review of previous literature.","Within the first 15 minutes after CPB weaning.",{"measure":19,"description":20,"timeFrame":21},"To identify risk factors associated with a higher R-Ao gradient, based on patient biometric parameters and surgical variables","Patient variables: age, body surface area \\[BSA\\], radial artery diameter Surgery variables: CPB duration and use of hypothermia Outcome Measure: Odds Ratio","From enrollment to 48 hours after surgery",{"measure":23,"description":24,"timeFrame":25},"To compare vasoactive drug requirements\u002Fdosages between patients with and without a significant arterial gradient","The comparison will be made using VIS score, as:\n\nVIS = dopamine + dobutamine + (100 × epinephrine) + (100 × norepinephrine) + (10 × milrinone) + (10,000 × vasopressin)\n\nIt will be measured at three time periods: 30 mins post CPB, Postoperative Day 1 and Postoperative Day 2","within 30 minutes from the weaning of the CBP, up to 48 hours after surgery.",{"measure":27,"description":28,"timeFrame":29},"To compare the duration of invasive mechanical ventilation between patients with and without a significant arterial gradient.",null,"within the first 48 hours following weaning of the CBP",{"measure":31,"description":28,"timeFrame":29},"To compare the incidence of post-CPB blood transfusion between patients with and without a significant arterial gradient.",{"measure":33,"description":28,"timeFrame":34},"To compare the incidence of renal dysfunction between patients with and without a significant arterial gradient.","within 48 hours following weaning of the CBP",{"allocation":28,"interventionModel":28,"interventionModelDescription":28,"primaryPurpose":28,"observationalModel":36,"timePerspective":37,"maskingInfo":28},"COHORT","PROSPECTIVE","Accurate arterial blood pressure monitoring is essential during and after cardiopulmonary bypass (CPB) in pediatric cardiac surgery. However, a significant gradient between radial and central aortic pressure has been reported, which could lead to erroneous clinical decisions if radial pressure is overestimated. Although this phenomenon has been studied in adults, its incidence, associated factors, and clinical implications in pediatric patients under 3 years of age remain to be clearly established.\n\nThis study proposes a prospective observational cohort design including 100 patients under 3 years of age undergoing cardiac surgery with CPB and invasive radial arterial monitoring. The study will evaluate the incidence of a significant radial-to-aortic gradient (defined as a \\>20% difference in SBP or \\>10% in MAP sustained for more than 5 minutes), alongside biometric and surgical risk factors, and its relationship with clinical outcomes such as vasoactive drug requirements, blood transfusions, and duration of mechanical ventilation.\n\nStatistical analysis will be performed using descriptive statistics, bivariate testing, and multivariate LASSO logistic regression. This study is expected to identify a pediatric risk profile for developing a significant pressure gradient, thereby optimizing decision-making regarding arterial monitoring sites and post-CPB hemodynamic management. Ultimately, this research aims to address a clinically relevant knowledge gap and enhance perioperative safety in this highly vulnerable population.","Pediatric patients from 0-3 years of age",[41],{"label":42,"type":28,"description":43,"interventionNames":44},"Study group","Patients under 3 years of age undergoing cardiac surgery with cardiopulmonary bypass (CPB) at the UC-Christus Clinical Hospital.",[45],"Other: Placement of a pressure transducer at the accessory port of the CPB arterial cannula",[47],{"type":6,"name":48,"description":49,"armGroupLabels":50,"otherNames":28},"Placement of a pressure transducer at the accessory port of the CPB arterial cannula","Placement of a pressure transducer at the accessory port of the cardiopulmonary bypass (CPB) arterial cannula during the final phase of CPB and the immediate post-CPB period.",[42],[52],{"name":53,"affiliation":54,"role":55},"Santiago Arze, MD","División de Anestesiología, Pontificia Universidad Católica de Chile","PRINCIPAL_INVESTIGATOR",[57,61],{"name":53,"role":58,"phone":59,"phoneExt":28,"email":60},"CONTACT","+56955049217","sarze@uc.cl",{"name":62,"role":58,"phone":63,"phoneExt":28,"email":64},"Valeria Pizarro, MD","+56962283715","vale.pizarro@uc.cl",[66,80],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":28},"Pontificia Universidad Católica de Chile","RECRUITING","Santiago","Santiago Metropolitan","8320000","Chile","CL",{"type":75,"coordinates":76},"Point",[77,78],-70.64827,-33.45694,{"lat":78,"lon":77},{"facility":81,"status":68,"city":69,"state":70,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":82,"geoPoint":84,"contacts":28},"Red de Salud UC Christus",{"type":75,"coordinates":83},[77,78],{"lat":78,"lon":77},{"type":86,"investigatorFullName":28,"investigatorTitle":28,"investigatorAffiliation":28,"oldNameTitle":28,"oldOrganization":28},"SPONSOR","100658873","evaluation-of-aortic-radial-blood-pressure-gradient-in-pediatric-patients-undergoing-cardiac-surgery-with-cardiopulmonary-bypass-100658873",false,"NCT07857811","Evaluation of Aortic-Radial Blood Pressure Gradient in Pediatric Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass","GARP","Inclusion Criteria:\n\n* Patients from 0 to 3 years old\n* Cardiac surgery with cardiopulmonary bypass (CPB)\n* Invasive blood pressure monitoring via radial artery\n\nExclusion Criteria:\n\n* Patients in whom radial cannulation is not achieved\n* Significant vascular malformations that may interfere with or contraindicate invasive radial blood pressure measurement\n* Emergency surgeries\n* Reinterventions during the same hospital stay\n* Technical complications preventing reliable direct aortic pressure measurement","ALL","0 Years","3 Years",{"count":98,"type":99},100,"ESTIMATED","2 Days","OBSERVATIONAL","Invasive blood pressure monitoring is essential during heart surgery. Usually, doctors measure blood pressure using a small tube (a catheter) placed in an artery, typically in the wrist or arm. During surgeries that require a heart-lung machine (cardiopulmonary bypass), doctors can also measure blood pressure directly near the heart in the main artery (the aorta). This is done using a tube already in place for the machine, so no extra procedure is needed.\n\nIn adult patients, doctors have noticed that blood pressure readings taken at the arm can sometimes be significantly different from readings taken near the heart right after coming off the heart-lung machine. This difference could lead to unnecessary or incorrect treatments if medical teams rely only on arm readings. However, it is still unknown whether this same difference occurs in children.\n\nThe goal of this study is to measure and compare blood pressure from both the arm and near the heart in children aged 3 years and younger as they come off the heart-lung machine during heart surgery. This research will help medical teams make safer, more accurate treatment decisions for children undergoing heart surgery.",[104],"Gradient Between Radial and Central Aortic Pressure After Cardiopulmonary Bypass",[106,107,108,109],"Pressure gradient","Radial Aortic pressure gradient","cardiopulmonary bypass","Pediatric cardiac surgery","2026-09-29",{"date":112,"type":113},"2026-10-05","ACTUAL",{"date":115,"type":113},"2026-04-20",{"date":117,"type":99},"2028-04-21",{"name":5,"class":6},2]