Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-01 @ 9:37 AM
Study NCT ID:
NCT05492968
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002303', 'term': 'Cardiac Output, Low'}, {'id': 'D016534', 'term': 'Cardiac Output, High'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}, {'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D010656', 'term': 'Phenylephrine'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-17', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-08-05', 'lastUpdatePostDateStruct': {'date': '2022-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tertiary Outcome 1: NT-proBNP', 'timeFrame': 'Within the first three postoperative days', 'description': 'Maximum concentration of NT-proBNP in the first three postoperative days'}, {'measure': 'Tertiary Outcome 2: Troponin T', 'timeFrame': 'Within the first three postoperative days', 'description': 'Maximum concentration of Troponin T in the first three postoperative days'}, {'measure': 'Tertiary Outcome 3: Copeptin', 'timeFrame': 'Within the first three postoperative days', 'description': 'Maximum concentration of Copeptin in the first three postoperative days'}, {'measure': 'Exploratory Outcome 1:', 'timeFrame': 'Within the first three postoperative days', 'description': 'Incidence of MINS'}, {'measure': 'Exploratory Outcome 2:', 'timeFrame': 'Through study completion, on average 7 days', 'description': 'Incidence of atrial fibrillation'}, {'measure': 'Exploratory Outcome 3:', 'timeFrame': 'During hospitalization, on average 7 days', 'description': 'Incidence of acute kidney injury'}, {'measure': 'Exploratory Outcome 4:', 'timeFrame': 'During hospitalization, on average 7 days', 'description': 'Incidence of myocardial infarction'}, {'measure': 'Exploratory Outcome 5:', 'timeFrame': 'During hospitalization, on average 7 days', 'description': 'Incidence of stroke'}, {'measure': 'Exploratory Outcome 6:', 'timeFrame': 'During hospitalization, on average 7 days', 'description': 'Incidence of wound related complications'}], 'primaryOutcomes': [{'measure': 'Intraoperative cardiac output', 'timeFrame': 'Intraoperative', 'description': 'Time weighted average of intraoperative cardiac output'}], 'secondaryOutcomes': [{'measure': 'Secondary Outcome 1: Intraoperative brain regional oxygen saturation', 'timeFrame': 'Intraoperative', 'description': 'Time weighted average of intraoperative brain regional oxygen saturation'}, {'measure': 'Secondary Outcome 2: Intraoperative tissue regional oxygen saturation', 'timeFrame': 'Intraoperative', 'description': 'Time weighted average of intraoperative tissue regional oxygen saturation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Norepinephrine', 'Epinephrine', 'Phenylephrine', 'Major abdominal surgery', 'Intraoperative Cardiac Output', 'Intraoperative Hemodynamic', 'Intraoperative Perfusion'], 'conditions': ['Cardiac Output, Low', 'Cardiac Output, High', 'Perfusion; Complications']}, 'descriptionModule': {'briefSummary': 'The use of catecholamines for blood pressure and hemodynamic management is essential during undergoing surgery. The type of the catecholamine with the most clinical meaningful effect is still unknown. Therefore, the investigators evaluate the effect of intraoperative continuous infusion of epinephrine, norepinephrine and phenylephrine on intraoperative cardiac output. The investigators further evaluate the effect of epinephrine, norepinephrine and phenylephrine on regional brain and regional tissue oxygenation during surgery.', 'detailedDescription': 'Background: The use of catecholamines for blood pressure and hemodynamic management is essential during undergoing surgery. The type of the catecholamine with the most clinical meaningful effect is still unknown. Therefore, the investigators evaluate the effect of intraoperative continuous infusion of epinephrine, norepinephrine and phenylephrine on intraoperative cardiac output. The investigators further evaluate the effect of epinephrine, norepinephrine and phenylephrine on regional brain and regional tissue oxygenation during surgery.\n\nMethods: The study will include 225 patients ≥ 45 years of age undergoing moderate- to high-risk major open abdominal surgery lasting at least two hours in this prospective double-blinded randomized clinical trial. Patients will be randomly assigned to receive a continuous infusion of epinephrine, norepinephrine or phenylephrine for intraoperative blood pressure management. The primary outcome will be time weighted average (TWA) of cardiac output between continuous infusion of epinephrine, norepinephrine or phenylephrine. The secondary outcomes will be time weighted average of intraoperative brain regional oxygen saturation (brSO2) and tissue regional oxygen saturation (trSO2) between the groups.\n\nStatistics: For the primary outcome, TWA of intraoperative cardiac output between the groups will be analyzed using an ANOVA. The primary outcome, TWA of intraoperative brSO2 and TWA of intraoperative trSO2 will be analysed using an ANOVA.\n\nLevel of originality: Data regarding the hemodynamic effects of commonly used intraoperative vasopressors on cardiac output are limited. In detail, effects of different types of catecholamines on hemodynamic parameters and subsequently tissue perfusion in the operative setting are lacking. This study will give further information of the different hemodynamic effects of the most used clinical used catecholamines which are used for intraoperative blood pressure management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 45 years old\n* Scheduled for moderate- to high-risk major open abdominal surgery expected to last at least two hours\n* ASA physical status ≥ 2\n* At least one of the following risk factors:\n\n 1. Age ≥75years\n 2. History of peripheral arterial disease\n 3. History of coronary artery disease\n 4. History of stroke or transient ischemic attack/Stroke\n 5. History of chronic kidney disease\n 6. Diabetes requiring medical treatment\n 7. Current smoking or history of 15 pack-years\n 8. History of heart failure\n 9. Preoperative high-sensitivity Troponin T ≥14ng.L-1\n 10. Preoperative NT-proBNP ≥200 pg.mL-1\n\nExclusion Criteria:\n\n1. Scheduled for pheochromocytoma surgery\n2. Scheduled for liver and kidney transplantation\n3. Requiring preoperative intravenous vasopressor medications\n4. Contraindications to epinephrine, norepinephrine or phenylephrine per clinical judgement\n5. Permanent atrial fibrillation\n6. Preoperative heart rate \\>110 bpm'}, 'identificationModule': {'nctId': 'NCT05492968', 'acronym': 'RACE', 'briefTitle': 'The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'The Effect of Epinephrine, Norepinephrine and Phenylephrine on Intraoperative Hemodynamic Performance - a Prospective Double-blinded Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RACE_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epinephrine Group', 'description': 'Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'interventionNames': ['Drug: Epinephrin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Norepinephrine Group', 'description': 'Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Phenylephrine Group', 'description': 'Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'interventionNames': ['Drug: Phenylephrine']}], 'interventions': [{'name': 'Epinephrin', 'type': 'DRUG', 'description': 'Patients in the epinephrine group will receive a continuous infusion containing epinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'armGroupLabels': ['Epinephrine Group']}, {'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'Patients in the norepinephrine group will receive a continuous infusion containing norepinephrine with a concentration of 0.02mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'armGroupLabels': ['Norepinephrine Group']}, {'name': 'Phenylephrine', 'type': 'DRUG', 'description': 'Patients in the phenylephrine group will receive a continuous infusion containing phenylephrine with a concentration of 0.2mg/ml for intraoperative blood pressure management. The infusion will be started with 0.15mL/kg/h and will be titrated to receive a mean arterial pressure of at least 75mmHg.', 'armGroupLabels': ['Phenylephrine Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Christian Reiterer, MD', 'role': 'CONTACT', 'email': 'christian.reiterer@meduniwien.ac.at', 'phone': '004340400', 'phoneExt': '20760'}], 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Christian Reiterer, MD', 'role': 'CONTACT', 'email': 'christian.reiterer@meduniwien.ac.at', 'phone': '0043 1 40400', 'phoneExt': '20760'}, {'name': 'Alexander Taschner, MD', 'role': 'CONTACT', 'email': 'alexander.taschner@meduniwien.ac.at', 'phone': '004340400', 'phoneExt': '20760'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Graz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christian Reiterer', 'investigatorAffiliation': 'Medical University of Vienna'}}}}