Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2025-12-29 @ 12:15 AM
Study NCT ID:
NCT06917859
Status:
RECRUITING
Last Update Posted:
2025-04-09
First Post:
2025-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-04', 'studyFirstSubmitDate': '2025-02-14', 'studyFirstSubmitQcDate': '2025-04-04', 'lastUpdatePostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of occurrence of postoperative acute kidney injury', 'timeFrame': '7 days post-operative', 'description': 'Incidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.'}], 'secondaryOutcomes': [{'measure': 'Incidence of postoperatively hyperglycemia', 'timeFrame': '7 days post-operative', 'description': '1\\. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl).'}, {'measure': 'Duration of ICU stay,', 'timeFrame': '7 days post-operative', 'description': 'Duration of ICU stay,'}, {'measure': 'Length of hospital stay', 'timeFrame': '14 Day post-operative', 'description': 'Length of hospital stay'}, {'measure': 'Incidence of wound infection', 'timeFrame': '7 days post-operative', 'description': 'Incidence of wound infection'}, {'measure': 'Incidence of peptic ulcer', 'timeFrame': '7 days post-operative', 'description': 'Monitoring attacks of hematemesis or melena'}, {'measure': 'Incidence of sepsis', 'timeFrame': '7 days post-operative', 'description': 'Incidence of sepsis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AKI', 'CPB'], 'conditions': ['Cardiopulmonary Bypass', 'AKI - Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The aim of the planned study is to assess the prophylactic effect of intraoperative administration of a single dose of methylprednisolone 2 (mg/kg) in decreasing the incidence of postoperative acute kidney injury after cardiac surgeries with cardiopulmonary bypass.', 'detailedDescription': 'Patients undergoing any type of elective cardiac surgical procedure requiring CPB will be randomly assigned into one of the following groups\n\n1. Placebo group / Control group will receives normal saline as a placebo after the induction of anesthesia and before initiating CPB.\n2. Methylprednisolone group / Interventional group receives a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.\n\nMeasurements:\n\nPrimary outcome:\n\nIncidence of occurrence of postoperative acute kidney injury for 7 days according to the RIFLE criteria.\n\nSecondary outcome:\n\n1. Incidence of postoperatively hyperglycemia (blood glucose level of ≥ 140 mg/dl) for 7 days,\n2. Duration of ICU stay,\n3. Length of hospital stay (LOS),\n4. Incidence of wound infection,\n5. Incidence of peptic ulcer,\n6. Incidence of sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-65 years.\n2. Sex: Both sexes.\n3. Patients with American Society of Anesthesiologists (ASA) score III-IV.\n4. Patients scheduled for any kind of elective cardiac surgical procedure requiring cardiopulmonary bypass (e.g., coronary artery bypass grafting (CABG), valve repair/replacement, or combined procedures (\n\nExclusion Criteria:\n\n1. Declining to give written informed consent.\n2. History of allergy to the medications used in the study.\n3. Diabetic patients with HbA1C \\>6.5\n4. Moderate to severe hepatic diseases (Child B-C)\n5. Hepatic dysfunction: INR \\> 1.5, serum albumin \\< 2.9 g%.\n6. Renal dysfunction (serum Creatinine level \\>1.3 mg/dl, or GFR \\< 80 ml/min./1.73/m2\n7. Patients with a recent history of AKI.\n8. Patients undergoing urgent cardiac surgery.\n9. Patients undergoing cardiac surgeries with deep hypothermic total circulatory arrest.\n10. Planned off-pump procedure.\n11. Any cardiac surgery exceeds 45 minutes on Aortic cross clamp.\n12. Patients requiring high doses of inotropes and/or vasopressors intraoperative or postoperative (high-dose dopamine is defined as peak doses of \\>15 μg/kg/min, high-dose norepinephrine is defined as peak dose \\>0.1 μg/kg/min, high-dose epinephrine is defined as peak dose \\>0.1 μg/kg/min)\n13. Delayed extubation for more than 6 hours postoperative.\n14. Patients developed postoperative complications as (septic shock and bleeding)'}, 'identificationModule': {'nctId': 'NCT06917859', 'briefTitle': 'Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Prophylactic Methylprednisolone for Renal Protection in Cardiac Surgeries With Cardiopulmonary Bypass: A Randomized Double-Blinded Clinical Study', 'orgStudyIdInfo': {'id': 'MD47/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': '(Placebo group / Control group) will receive normal saline as a placebo after the induction of anesthesia and before initiating CPB.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Methylprednisolone group', 'description': '(Methylprednisolone group ) receive a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.', 'interventionNames': ['Drug: Methylprednisolone group']}], 'interventions': [{'name': 'Methylprednisolone group', 'type': 'DRUG', 'description': 'In this study patients will be given a single intra-venous dose of methylprednisolone (2 mg/kg) after the induction of anesthesia, and before the initiation of CPB.', 'armGroupLabels': ['Methylprednisolone group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00202', 'city': 'Cairo', 'state': 'Abbasia', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Abdelrahman Atef Dr.Abdelrahman, M.B., B.Ch Faculty of Medicine', 'role': 'CONTACT', 'email': 'abdelrahman.atef@med.asu.edu.eg', 'phone': '01091541157'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Abdelrahman Atef Atef, M.B., B.Ch Faculty of Medicine', 'role': 'CONTACT', 'email': 'abdelrahman.atef@med.asu.edu.eg', 'phone': '+201091541157'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}