Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-30 @ 5:21 PM
Study NCT ID:
NCT05927233
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2023-06-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-06-22', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum levels of Interleukin- 6', 'timeFrame': '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', 'description': 'serum levels of Interleukin- 6 will be measured using ELISA'}, {'measure': 'Serum levels of CRP', 'timeFrame': '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', 'description': 'serum levels of CRP will be measured using ELISA'}], 'secondaryOutcomes': [{'measure': 'Serum creatinine level', 'timeFrame': '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'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Paediatric population'], 'conditions': ['Cyanotic Heart Disease', 'Cardiopulmonary Bypass']}, 'referencesModule': {'references': [{'pmid': '23602068', 'type': 'BACKGROUND', 'citation': 'Keski-Nisula J, Pesonen E, Olkkola KT, Peltola K, Neuvonen PJ, Tuominen N, Sairanen H, Andersson S, Suominen PK. Methylprednisolone in neonatal cardiac surgery: reduced inflammation without improved clinical outcome. Ann Thorac Surg. 2013 Jun;95(6):2126-32. doi: 10.1016/j.athoracsur.2013.02.013. Epub 2013 Apr 18.'}, {'pmid': '33045104', 'type': 'BACKGROUND', 'citation': 'Gibbison B, Villalobos Lizardi JC, Aviles Martinez KI, Fudulu DP, Medina Andrade MA, Perez-Gaxiola G, Schadenberg AW, Stoica SC, Lightman SL, Angelini GD, Reeves BC. Prophylactic corticosteroids for paediatric heart surgery with cardiopulmonary bypass. Cochrane Database Syst Rev. 2020 Oct 12;10(10):CD013101. doi: 10.1002/14651858.CD013101.pub2.'}]}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': '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 (\\< 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'}, 'identificationModule': {'nctId': 'NCT05927233', 'briefTitle': 'Effect of Methylprednisolone on Systemic Inflammatory Response During Pediatric Congenital Open-Heart Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Aga Khan University'}, 'officialTitle': 'Effect of Methylprednisolone on Systemic Inflammatory Response and Clinical Parameters During Pediatric Congenital Open-Heart Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021-6247-18639'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group M', 'description': 'IV Methylprednisolone', 'interventionNames': ['Drug: Methylprednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group P', 'description': 'IV Normal Saline', 'interventionNames': ['Drug: Saline']}], 'interventions': [{'name': 'Methylprednisolone', 'type': 'DRUG', 'description': '30 ml Methylprednisolone (30mg/kg) with a maximum dose of 500 mg', 'armGroupLabels': ['Group M']}, {'name': 'Saline', 'type': 'DRUG', 'description': '30 ml Normal saline', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74800', 'city': 'Karachi', 'state': 'Sindh', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Muhammad Saad Yousuf, MBBS, FCPS', 'role': 'CONTACT', 'email': 'saad.yousuf@aku.edu', 'phone': '00923003540362'}, {'name': 'mohammad Hamid, FCPS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Syed Shabir Ahmed, FCPS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Waris Ahmed, FRCS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khalid Samad, FCPS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Khalid Siddiqui, FCPS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhammad Saad Yousuf, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aga Khan University Hospital', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'centralContacts': [{'name': 'Muhammad Saad Yousuf, MBBS, FCPS', 'role': 'CONTACT', 'email': 'saad.yousuf@aku.edu', 'phone': '+923003540362'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aga Khan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Instructor', 'investigatorFullName': 'Dr. Muhammad Saad Yousuf', 'investigatorAffiliation': 'Aga Khan University'}}}}