Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2025-12-25 @ 9:10 PM
Study NCT ID:
NCT05222256
Status:
UNKNOWN
Last Update Posted:
2022-02-08
First Post:
2021-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Levosimendan and Adrenaline in CABG Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077464', 'term': 'Simendan'}, {'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D006835', 'term': 'Hydrazones'}, {'id': 'D006834', 'term': 'Hydrazines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011724', 'term': 'Pyridazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2024-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-06', 'studyFirstSubmitDate': '2021-12-06', 'studyFirstSubmitQcDate': '2022-02-02', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic function (EF) will be measured in both groups Levosemindan and Adrenaline in patients with low ejection fraction (30-40%), undergoing elective on pump Coronary Artery Bypass Graft (CABG).', 'timeFrame': '24 hour', 'description': "transesophageal echo (TEE) will be continuously used to monitor LV systolic and diastolic function during surgery and recordings will be made simultaneously with hemodynamic measurements. LV Ejection Fraction In the transgastric mid-papillary view, the echo machine will be switched to M-mode and the following measurements will be taken: o LV end-diastolic diameter o LV end-systolic diameter The machine will then calculate the LV ejection fraction according to Teich's method"}], 'secondaryOutcomes': [{'measure': 'LV Myocardial Performance (Tei) Index will be measured in both groups', 'timeFrame': '24 hour', 'description': 'The left ventricle myocardial performance index will be calculated by placing pulsed Doppler sample volume between the anterior leaflet of the mitral valve and the left ventricle outflow tract (LVOT) in the deep transgastric view. Tei index = (a-b)/b, where (a) = distance between the mitral A wave and E wave, and (b) = distance between the start and end of the LVOT flow)'}, {'measure': 'LV Stroke Volume and Cardiac Output will be measured in both groups', 'timeFrame': '24 hour', 'description': 'The LVOT diameter will be measured in the mid-esophagus long-axis view. Assuming that the LVOT is circular in shape, the LVOT cross-sectional area will be calculated . The velocity time integral (VTI) of LVOT will be determined by pulsed Doppler imaging in the deep transgastric view by tracing the LVOT ejection curve. The stroke volume (SV) will then be calculated as:\n\nStroke volume (cm3) = LVOT cross sectional area x LVOT VTI\n\nCardiac output (CO) will then be calculated as CO = SV x heart rate, and cardiac index (CI) will be calculated as CI = CO/body surface area.'}, {'measure': 'LV diastolic function will be measured in both groups', 'timeFrame': '24 hour', 'description': "In the mid-esophageal four-chamber view, E-wave velocity, A-wave velocity and E/A ratio will be determined by placing the sample volume of pulsed-wave Doppler at the tips of the mitral leaflets. Using tissue Doppler imaging, e'-wave velocity will be measured at both the lateral and septal mitral annulus, and the average of both measurements will be reported and used in subsequent calculations. The E/e' index will be calculated"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open Heart Surgery']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare between levosimendan and adrenaline in patients with pre-existing impaired systolic function (EF 30-40%), undergoing elective on-pump CABG, as regards hemodynamics and echocardiographic parameters.', 'detailedDescription': 'Patients undergoing cardiac surgery are at risk of post-cardiotomy myocardial dysfunction. This condition causes delayed recovery, organ failure, prolonged intensive care unit and hospital stays, and an increased risk of mortality. These patients often require inotropic support, which has been associated with an increased risk of cardiovascular complications. Treatment of myocardial dysfunction includes optimization of myocardial contractility through appropriate fluid and pharmacologic management and mechanical support . Extensive use of inotropes in this situation is needed, but the optimal pharmacologic management of myocardial dysfunction in cardiac surgery is a matter of ongoing debate .Available inotropes including adrenaline may increase myocardial oxygen consumption, heart rate and risk of arrhythmia. An increase in myocardial oxygen consumption by inotropes in a state of inadequate oxygen delivery may further deteriorate underlying cardiac dysfunction and even lead to increased mortality . There are questions regarding the ideal inotrope to use during the post cardiopulmonary bypass (CPB) period in patients undergoing on-pump CABG surgery. The occurrence of myocardial dysfunction after cardiac surgery is a potential indication for the use of levosimendan, a calcium sensitizer with a unique mechanism of action. By binding to cardiac troponin C, it enhances myofilament responsiveness to calcium, thereby increasing myocardial contraction without increasing myocardial oxygen consumption. In addition, levosimendan activates adenosine triphosphate-dependent potassium channels, which are important mediators of ischemic and anesthetic cardioprotection. Levosimendan might thus have a potential benefit for patients with myocardial oxygen imbalance requiring inotropic drug support . The hypothesis of the present study is that levosimendan without loading dose can improve myocardial function and provide better hemodynamics as well as echocardiographic parameters compared with adrenaline in patients with low ejection fraction undergoing op-pump CABG'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ischemic hear disease\n* age 18 and 65 years\n* low left ventricular function (ejection fraction 30 - 40%),\n* elective coronary artery bypass grafting (CABG) surgery\n\nExclusion Criteria:\n\n* Age over 65 years\n* Patients with end organ failure (renal, liver)\n* Associated significant valve lesions\n* Uncontrolled diabetes mellitus\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT05222256', 'briefTitle': 'Comparison Between Levosimendan and Adrenaline in CABG Patients', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Levosimendan Versus Adrenaline in Patients With Low Left Ventricular Function Undergoing Elective On-Pump Coronary Artery Bypass Graft Surgery. A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'Tee in open heart surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group (L) levosimendan group', 'description': 'Patients in this group will receive levosimendan (0.1 μg/kg/min) during re-warming of the patients.', 'interventionNames': ['Drug: Levosimendan']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group (A) Adrenaline group', 'description': 'Patients in this group will receive Adrenaline (0.05 μg /kg/min) during re-warming of the patients.', 'interventionNames': ['Drug: Adrenaline']}], 'interventions': [{'name': 'Levosimendan', 'type': 'DRUG', 'description': 'Patients in this group will receive levosimendan', 'armGroupLabels': ['Group (L) levosimendan group']}, {'name': 'Adrenaline', 'type': 'DRUG', 'description': 'Patients in this group will receive Adrenaline', 'armGroupLabels': ['Group (A) Adrenaline group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Abdelrahman Mohamed Abdelhafeez', 'role': 'CONTACT', 'email': 'feezoo15@gmail.com', 'phone': '00201112272212'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant lecturer of anesthesia and intensive care', 'investigatorFullName': 'Abdelrahman Mohamed Abdelhafeez Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}