Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-27 @ 2:04 PM
Study NCT ID:
NCT07144267
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-08-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Milrinone and Epinephrine on TAPSE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D020105', 'term': 'Milrinone'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000676', 'term': 'Amrinone'}, {'id': 'D000631', 'term': 'Aminopyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'anesthesiologist who performed TEE measurements and who was responsible for data collection will be blinded to patient group allocation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Epinephrine group (group E): the patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping.\n\nMilrinone group (group M): the patients receive initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 102}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-20', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tricuspid annular plane systolic excursion (TAPSE) within 5 minutes post-cardiopulmonary Bypass', 'timeFrame': 'within 5 mins post-cardiopulmonary bypass', 'description': 'measured by Transesophageal echocardiography (TEE)'}], 'secondaryOutcomes': [{'measure': 'Tricuspid annular plane systolic excursion (TAPSE)', 'timeFrame': 'within 30-60 minutes post-cardiopulmonary bypass', 'description': 'measured by Transesophageal echocardiography (TEE)'}, {'measure': 'Incidence of Right Ventricular Dysfunction after Cardiac Surgery', 'timeFrame': '24 hours postoperative', 'description': 'detected by ECHO when Tricuspid annular plane systolic excursion (TAPSE) ≤1.7 cm'}, {'measure': 'Incidence of Arrhythmias', 'timeFrame': 'intraoperatively and 24 hours postoperative', 'description': 'occurrence of any Arrhythmia'}, {'measure': 'Vasoactive-Inotrope Score (VIS)', 'timeFrame': 'recorded at 6, 12, 24, and 48 hours postoperative', 'description': 'Vasoactive-Inotrope Score = Dopamine (µg/kg/min) + Dobutamine (µg/kg/min) +100 x Epinephrine (µg/kg/min) +100 x Norepinephrine (µg/kg/min) + 10 x Milrinone (µg/kg/min) + 10,000 x Vasopressin'}, {'measure': 'Total consumption doses of Vasopressors', 'timeFrame': '48 hours postoperative', 'description': 'cumulative dose of any needed Vasopressors (Norepinepherine)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cardiopulmonary bypass (CPB) -Tricuspid annular plane systolic excursion (TAPSE)-', 'Epinephrine - Milrinone'], 'conditions': ['Cardiac Anaesthesia', 'Cardiopulmonary Bypass']}, 'descriptionModule': {'briefSummary': 'Cardiopulmonary bypass (CPB) is a critical technology in cardiac surgery, allowing for the temporary replacement of the heart and lung functions during intricate surgical procedures. it has significant post-surgical complications, the most important complications of CPB is right ventricle (RV) dysfunction. Diagnosis and management of RV dysfunction is crucial for maintenance of hemodynamic stability and organ function in early post-operation period and prognostic for later phase.', 'detailedDescription': 'Epinephrine is the most potent adrenergic agonist which has positive inotropic and chronotropic effects and enhanced conduction in the heart (β1), smooth muscle relaxation in the vasculature and bronchial tree (β2), and vasoconstriction (α1). Low doses of this agent (\\<0.1-0.2 μg/kg/min) mainly activate the β adrenoceptors with inotropic effects. Higher doses result in vasoconstrictor effect which takes the lead. Other effects include bronchial dilation, mydriasis, glycogenolysis, tachyarrhythmia, myocardial ischemia, pulmonary hypertension, hyperglycemia, and lactic acidosis. Epinephrine also reduces splanchnic and hepatic perfusion and increases metabolic workload of the liver. So this hypermetabolism that impairs oxygen exchange, glycolysis, and suppression of insulin cause lactic acidosis.\n\nMilrinone is a phosphodiesterase-III inhibitor. This effect decreases the degradation of cyclic adenosine monophosphate (cAMP), increases the cAMP levels in cells, and then increases activation of protein kinase A. Therefore, its cardiac effects are positive inotropy and improved diastolic relaxation. Milrinone also causes potent vasodilation, with reduction in preload, afterload and pulmonary vascular resistance. Considering its characteristics, milrinone might be a useful agent for cardiac surgery patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status II \\& III\n* Age between 18 and 70 years\n* Both Gender\n* Body mass index less than 40 kg/m2\n* Ejection fraction of \\>40%\n* Tricuspid annular plane systolic excursion (TAPSE) \\< 1.7cm\n\nExclusion Criteria:\n\n* Patient refusal.\n* Preoperative RV impairment\n* Pulmonary hypertension (estimated pulmonary artery systolic pressure \\> 50 mmHg)\n* Patients with any contraindications to Transesophageal echocardiography (TEE)\n* Redo or Re-exploration surgery\n* Patients with chronic kidney disease (serum creatinine \\> 1.5 mg/ dl)\n* Patients with chronic liver disease (child pugh B and C)'}, 'identificationModule': {'nctId': 'NCT07144267', 'acronym': 'Milrinone', 'briefTitle': 'Comparison of Milrinone and Epinephrine on TAPSE', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Milrinone Versus Epinephrine for Right Ventricular Dysfunction After Cardiac Surgery in Adults: A Randomized Double-Blinded Trial', 'orgStudyIdInfo': {'id': 'Milrinone on TAPSE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Epinephrine group (group E)', 'description': 'The patients receive 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping', 'interventionNames': ['Drug: Epinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Milrinone group (group M)', 'description': 'patients will recieve an initial bolus dose of of 50 µg/kg, followed by 0.40 -0.80 µg/kg/min 5-10 minutes before aortic unclamping', 'interventionNames': ['Drug: Milrinone Injection']}], 'interventions': [{'name': 'Epinephrine', 'type': 'DRUG', 'description': 'Normal saline bolus over 10 min followed by Epinephrine intravenous infusion of 0.05-0.1 mcg/kg/min.of epinephrine 5-10 minutes before aortic unclamping', 'armGroupLabels': ['Epinephrine group (group E)']}, {'name': 'Milrinone Injection', 'type': 'DRUG', 'description': 'Milrinone initial bolus doses of 50 µg/kg, followed by 0.40 - 0.80 µg/kg/min of milrinone 5-10 minutes before aortic unclamping', 'armGroupLabels': ['Milrinone group (group M)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Maha A AboZeid, Assistant professor', 'role': 'CONTACT', 'email': 'mahazed@yahoo.com', 'phone': '01019216192', 'phoneExt': '02'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesia , surgical Intensive care and pain management Faculty of Medicine', 'investigatorFullName': 'maha abou-zeid', 'investigatorAffiliation': 'Mansoura University'}}}}