[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510499":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":19,"armGroups":30,"interventions":43,"overallOfficials":19,"centralContacts":53,"locations":59,"responsibleParty":91,"collaborators":19,"id":94,"slug":19,"hasResults":95,"nctId":96,"briefTitle":97,"officialTitle":98,"acronym":19,"eligibilityCriteria":99,"healthyVolunteers":95,"sex":100,"minAge":101,"maxAge":102,"enrollmentInfo":103,"targetDuration":19,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":113,"overallStatus":62,"whyStopped":19,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Aga Khan University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":19},[9,13],{"measure":10,"description":11,"timeFrame":12},"Serum levels of Interleukin- 6","serum levels of Interleukin- 6 will be measured using ELISA","Before the first dose of steroid), second sample will be drawn after immediately protamine infusion, third sample at 24 hours after CPB and the fourth sample will be drawn at 48 hours after CPB",{"measure":14,"description":15,"timeFrame":12},"Serum levels of CRP","serum levels of CRP will be measured using ELISA",[17],{"measure":18,"description":19,"timeFrame":12},"Serum creatinine level",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":25,"maskingDescription":19,"whoMasked":26},"TRIPLE",[27,28,29],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Group M","EXPERIMENTAL","IV Methylprednisolone",[36],"Drug: Methylprednisolone",{"label":38,"type":39,"description":40,"interventionNames":41},"Group P","PLACEBO_COMPARATOR","IV Normal Saline",[42],"Drug: Saline",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":19},"DRUG","Methylprednisolone","30 ml Methylprednisolone (30mg\u002Fkg) with a maximum dose of 500 mg",[32],{"type":45,"name":50,"description":51,"armGroupLabels":52,"otherNames":19},"Saline","30 ml Normal saline",[38],[54],{"name":55,"role":56,"phone":57,"phoneExt":19,"email":58},"Muhammad Saad Yousuf, MBBS, FCPS","CONTACT","+923003540362","saad.yousuf@aku.edu",[60],{"facility":61,"status":62,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Aga Khan University Hospital","RECRUITING","Karachi","Sindh","74800","Pakistan","PK",{"type":69,"coordinates":70},"Point",[71,72],67.0104,24.8608,{"lat":72,"lon":71},[75,77,80,82,84,86,88],{"name":55,"role":56,"phone":76,"phoneExt":19,"email":58},"00923003540362",{"name":78,"role":79,"phone":19,"phoneExt":19,"email":19},"mohammad Hamid, FCPS","SUB_INVESTIGATOR",{"name":81,"role":79,"phone":19,"phoneExt":19,"email":19},"Syed Shabir Ahmed, FCPS",{"name":83,"role":79,"phone":19,"phoneExt":19,"email":19},"Waris Ahmed, FRCS",{"name":85,"role":79,"phone":19,"phoneExt":19,"email":19},"Khalid Samad, FCPS",{"name":87,"role":79,"phone":19,"phoneExt":19,"email":19},"Khalid Siddiqui, FCPS",{"name":89,"role":90,"phone":19,"phoneExt":19,"email":19},"Muhammad Saad Yousuf, FCPS","PRINCIPAL_INVESTIGATOR",{"type":90,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Dr. Muhammad Saad Yousuf","Senior Instructor","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":104,"type":105},60,"ESTIMATED","INTERVENTIONAL",[108],"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).",[111,112],"Cyanotic Heart Disease","Cardiopulmonary Bypass",[114],"Paediatric population","2024-07-30",{"date":117,"type":118},"2024-07-31","ACTUAL",{"date":120,"type":118},"2023-04-01",{"date":122,"type":105},"2025-06-30",{"name":5,"class":6},1]