[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510499":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":69,"collaborators":26,"id":72,"slug":73,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":26,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Aga Khan University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group M","EXPERIMENTAL","IV Methylprednisolone",[13],"Drug: Methylprednisolone",{"label":15,"type":16,"description":17,"interventionNames":18},"Group P","PLACEBO_COMPARATOR","IV Normal Saline",[19],"Drug: Saline",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Methylprednisolone","30 ml Methylprednisolone (30mg\u002Fkg) with a maximum dose of 500 mg",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Saline","30 ml Normal saline",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Muhammad Saad Yousuf, MBBS, FCPS","CONTACT","+923003540362","saad.yousuf@aku.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Aga Khan University Hospital","RECRUITING","Karachi","Sindh","74800","Pakistan","PK",{"type":47,"coordinates":48},"Point",[49,50],67.0104,24.8608,{"lat":50,"lon":49},[53,55,58,60,62,64,66],{"name":33,"role":34,"phone":54,"phoneExt":26,"email":36},"00923003540362",{"name":56,"role":57,"phone":26,"phoneExt":26,"email":26},"mohammad Hamid, FCPS","SUB_INVESTIGATOR",{"name":59,"role":57,"phone":26,"phoneExt":26,"email":26},"Syed Shabir Ahmed, FCPS",{"name":61,"role":57,"phone":26,"phoneExt":26,"email":26},"Waris Ahmed, FRCS",{"name":63,"role":57,"phone":26,"phoneExt":26,"email":26},"Khalid Samad, FCPS",{"name":65,"role":57,"phone":26,"phoneExt":26,"email":26},"Khalid Siddiqui, FCPS",{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Muhammad Saad Yousuf, FCPS","PRINCIPAL_INVESTIGATOR",{"type":68,"investigatorFullName":70,"investigatorTitle":71,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Dr. Muhammad Saad Yousuf","Senior Instructor","100510499","phase-4-effect-of-methylprednisolone-on-systemic-inflammatory-response-during-pediatric-congenital-open-heart-surgery-100510499",false,"NCT05927233","Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery","Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children 1 month- 18 years of age\n* Undergoing Cardiac surgery for the first time and requiring CPB\n* Surgeries for both cyatonic and acyanotic heart disease\n\nExclusion Criteria:\n\n* Pre-mature babies (\\\u003C 28 weeks at birth)\n* Neonates\n* Prior cardiac requiring CPB\n* Surgeries requiring CPB \\> 6 hours\n* Surgeries requiring second run of CPB\n* Patients requiring additional steroids during first 24 hours of CICU stay\n* Patient expires within the initial 24 hours CICU stay.\n* Compromised immune system - that is, known immunodeficiency or use of\n* immunomodulatory therapy.\n* Peri-operative presence of two or more clinical or laboratory signs of active infection that were not attributable to any other cause: fever more than 100°F, heart rate or respiratory rate more than the normal range for age, white blood cell count more than 15% of the upper limit of normal, and an elevated C-reactive protein level above baseline.\n* Preoperative mechanical ventilation, and preoperative need of inotropic agents or mechanical circulatory support.\n* Patient already receiving steroids","ALL","1 Month","18 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"PHASE4","The goal of this study is to evaluate the effects of steroids on the early postoperative inflammatory response in patients undergoing elective pediatric congenital cardiac surgery, requiring cardiopulmonary bypass (CPB).",[90,91],"Cyanotic Heart Disease","Cardiopulmonary Bypass",[93],"Paediatric population","2024-07-30",{"date":96,"type":97},"2024-07-31","ACTUAL",{"date":99,"type":97},"2023-04-01",{"date":101,"type":84},"2025-06-30",{"name":5,"class":6},1]