[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636649":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":24,"studyPopulation":25,"armGroups":26,"interventions":34,"overallOfficials":53,"centralContacts":57,"locations":62,"responsibleParty":73,"collaborators":20,"id":76,"slug":20,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":20,"maxAge":84,"enrollmentInfo":85,"targetDuration":20,"studyType":88,"phases":20,"briefSummary":89,"conditions":90,"keywords":93,"overallStatus":99,"whyStopped":20,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Konya City Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Correlation between PRAM-derived Cardiac Index and Cerebral NIRS (rSO2c)","Pearson or Spearman correlation coefficient between cardiac index (CI, L\u002Fmin\u002Fm²) measured by MostCare™ (PRAM method) and cerebral regional oxygen saturation (rSO2c, %) measured by INVOS™ oximeter at four intraoperative time points.","Intraoperative (at 4 time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery)",[14,17],{"measure":15,"description":16,"timeFrame":12},"Correlation between PRAM-derived Cardiac Index and Renal NIRS (rSO2r)","Pearson or Spearman correlation coefficient between cardiac index (CI, L\u002Fmin\u002Fm²) and renal regional oxygen saturation (rSO2r, %) at four intraoperative time points.",{"measure":18,"description":19,"timeFrame":12},"Correlation between PRAM-derived Cardiac Index and Arterial Lactate Level","Pearson or Spearman correlation coefficient between cardiac index (CI, L\u002Fmin\u002Fm²) and arterial lactate level (mmol\u002FL) at four intraoperative time points.",null,{"allocation":20,"interventionModel":20,"interventionModelDescription":20,"primaryPurpose":20,"observationalModel":22,"timePerspective":23,"maskingInfo":20},"COHORT","PROSPECTIVE","Low cardiac output syndrome (LCOS) is a major determinant of postoperative morbidity and mortality in neonatal cardiac surgery, particularly in lesions affecting systemic circulation such as aortic coarctation. Reliable intraoperative assessment of cardiac output is therefore critical in this patient population.\n\nThe MostCare™ system uses the Pressure Recording Analytical Method (PRAM) to provide real-time, calibration-free cardiac index (CI) measurement derived solely from the arterial pressure waveform. Previous studies in infants have demonstrated good correlation between PRAM and echocardiography; however, data in neonates weighing less than 3.5 kg remain very limited.\n\nNear-infrared spectroscopy (NIRS) allows non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2), serving as an early indicator of tissue oxygenation. Arterial lactate is a biochemical marker of cellular hypoperfusion and is strongly associated with postoperative outcomes.\n\nIn this study, CI (MostCare™), cerebral and renal NIRS (INVOS™ oximeter), and arterial lactate will be simultaneously recorded at four intraoperative time points in neonates and infants undergoing aortic coarctation repair. The primary aim is to assess the correlation between PRAM-derived CI and cerebral NIRS. Secondary aims include the correlation between CI and renal NIRS, and between CI and arterial lactate levels.","Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg diagnosed with aortic coarctation and scheduled for surgical repair at SBU Konya City Hospital, Konya, Turkey.",[27],{"label":28,"type":20,"description":29,"interventionNames":30},"Aortic Coarctation Surgery Group","Neonates and infants aged 0-3 months with body weight 2.5-3.5 kg undergoing surgical repair of aortic coarctation. Cardiac index (MostCare™\u002FPRAM), cerebral and renal NIRS (INVOS™), and arterial lactate levels are recorded at four intraoperative time points under standard anesthesia protocol.",[31,32,33],"Device: MostCare (PRAM)","Device: Near-Infrared Spectroscopy (NIRS)","Procedure: Arterial Blood Gas with Lactate",[35,42,48],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DEVICE","MostCare (PRAM)","Real-time, calibration-free cardiac index monitoring via arterial pressure waveform analysis using the MostCare™ system. Used as part of routine intraoperative hemodynamic monitoring.",[28],[41],"Pressure Recording Analytical Method",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Near-Infrared Spectroscopy (NIRS)","Non-invasive monitoring of regional cerebral and renal oxygen saturation (rSO2) using the INVOS™ oximeter as part of standard intraoperative care.",[28],[47],"INVOS Oximeter",{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":20},"PROCEDURE","Arterial Blood Gas with Lactate","Arterial blood gas sampling for lactate measurement at four intraoperative time points as part of routine clinical monitoring.",[28],[54],{"name":55,"affiliation":5,"role":56},"Bedia Mine Hanedan, MD","PRINCIPAL_INVESTIGATOR",[58],{"name":55,"role":59,"phone":60,"phoneExt":20,"email":61},"CONTACT","+905059269595","bediaminech@gmail.com",[63],{"facility":64,"status":20,"city":65,"state":20,"zip":20,"country":66,"countryCode":20,"cosmosGeoPoint":67,"geoPoint":72,"contacts":20},"SBÜ Konya Şehir Hastanesi","Konya","Turkey (Türkiye)",{"type":68,"coordinates":69},"Point",[70,71],32.48464,37.87135,{"lat":71,"lon":70},{"type":56,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"BEDİA MİNE HANEDAN","Principal Investigator","100636649",false,"NCT07568431","Correlation of Cardiac Index Measured by the PRAM Method With NIRS and Lactate Levels in Pediatric Aortic Coarctation Surgery","Correlation of Cardiac Index Measured by the Pressure Recording Analytical Method (PRAM) With Near-Infrared Spectroscopy (NIRS) and Arterial Lactate Levels in Neonates and Infants Undergoing Surgical Repair of Aortic Coarctation: A Prospective Observational Study","MostCare-Ped","Inclusion Criteria:\n\n* Neonates and infants planned for surgical repair of aortic coarctation\n* Body weight between 2.5 and 3.5 kg\n* Postnatal age between 0 and 3 months\n* Considered hemodynamically stable for anesthesia and surgery\n* Written informed consent obtained from legal guardians\n\nExclusion Criteria:\n\n* Severe multiorgan dysfunction\n* Additional major congenital heart defect (e.g., Tetralogy of Fallot, Transposition of Great Arteries, Hypoplastic Left Heart Syndrome)\n* Surgery requiring cardiopulmonary bypass\n* Preoperative metabolic acidosis or sepsis\n* Inability to obtain informed consent from legal guardians","ALL","3 Months",{"count":86,"type":87},43,"ESTIMATED","OBSERVATIONAL","This prospective observational study aims to evaluate the correlation between cardiac index measured by the MostCare™ system (Pressure Recording Analytical Method, PRAM) and cerebral\u002Frenal regional oxygen saturation measured by near-infrared spectroscopy (NIRS) and arterial lactate levels in neonates and infants (body weight 2.5-3.5 kg, age 0-3 months) undergoing surgical repair of aortic coarctation. Measurements will be recorded at four intraoperative time points: after anesthesia induction, before aortic cross-clamp, 3 minutes after cross-clamp release, and at end of surgery. No additional intervention beyond standard anesthesia and surgical care will be applied.",[91,92],"Aortic Coarctation","Cardiac Output, Low",[94,95,96,97,98,91],"PRAM","Near-Infrared Spectroscopy","Cardiac Index","Pediatric Cardiac Surgery","Lactate","NOT_YET_RECRUITING","2026-04-28",{"date":102,"type":103},"2026-05-05","ACTUAL",{"date":105,"type":87},"2026-05",{"date":107,"type":87},"2027-03",{"name":5,"class":6},1]