Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-30 @ 6:14 PM
Study NCT ID:
NCT01601795
Status:
COMPLETED
Last Update Posted:
2014-01-29
First Post:
2012-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015428', 'term': 'Myocardial Reperfusion Injury'}], 'ancestors': [{'id': 'D009202', 'term': 'Cardiomyopathies'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D007530', 'term': 'Isoflurane'}], 'ancestors': [{'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2012-05-02', 'studyFirstSubmitQcDate': '2012-05-17', 'lastUpdatePostDateStruct': {'date': '2014-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative maximum Troponin levels', 'timeFrame': '24 hours'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic stability during on-pump', 'timeFrame': '2 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cardioprotection'], 'conditions': ['Myocardial Reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'The use of volatile anesthetics in cardiac anesthesia is very common, because of their cardioprotective effects and their ability to ensure a sufficient depth of anesthesia. In line with the development of fast track concepts in cardiac anesthesia, volatile anesthetics are widely used to avoid a delayed recovery from cardiac surgery and anesthesia. Volatile anesthetics are delivered from calibrated vaporizers in the anesthesia machine or the cardiopulmonary bypass machine (during extracorporeal circulation).\n\nIsoflurane and Sevoflurane are the most commonly used volatile anesthetics in patients undergoing cardiopulmonary bypass (CPB). The vaporizer of the anesthetics is on the cardiopulmonary bypass machine and the volatile agent is blended with air and oxygen. Until now, the pharmacokinetics of halothane, enflurane, isoflurane and desflurane during CPB have been described.\n\nSevoflurane might be of advantage because of additional myocardial protective effects during cardiac anesthesia and cardiopulmonary bypass. However, the pharmacokinetics of sevoflurane during CPB have not been investigated so far, although its being used at many hospitals.\n\nThe investigators will conduct a randomized prospective study with either sevoflurane or isoflurane during cardiopulmonary bypass surgery. The study will help to answer the questions about the possible cardioprotective effects of the widely used volatile anesthetics and the hemodynamic stability during cardiopulmonary bypass. Knowing the pharmacokinetics of these drugs allows the anesthesiologist to titrate the volatile anesthetics more precise.\n\nThe investigators hypothesizes that the maximal postoperative increase in troponin T will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the total amount of noradrenaline needed during the entire period of cardiopulmonary bypass will be smaller in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that kinetics of washin and washout at the CPB will be faster in the sevoflurane group than in the isoflurane group. The investigators hypothesizes that the time to extubation, respectively the length of stay in intensive care unit and hospital is shorter in the sevoflurane group than in the isoflurane group.', 'detailedDescription': 'Endpoints Primary Endpoint: Troponin\n\nThe study will compare the maximum postoperative troponin levels in the isoflurane and sevoflurane groups as a direct quantitative marker of damaged myocardial cells. Maximum troponin levels should be reached within the first 24 hours after surgery.\n\nSecondary Endpoints:\n\nA) Hemodynamic stability during on-pump\n\nThe investigators will compare the hemodynamic stability during CPB between the isoflurane and sevoflurane group. Therefore the total dosage of noradrenaline used during the surgery will be measured.\n\nB) Washin and Washout Kinetic\n\nKinetics of washin and washout of sevoflurane and isoflurane during CPB will be investigated and described.\n\nC) Extubation time and length of stay in the intensive care and in hospital\n\nTime to extubation and the length of stay in intensive care unit and in hospital will be documented.\n\nD) Mortality after 30 days\n\nThe mortality after 30 days will also be monitored. If the patient is no more in the hospital a phone call will be made.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective coronary bypass surgery\n* preserved left ventricular function (LVEF (left ventricular ejection fraction) \\>55%)\n* Age \\> 18 years\n* planned MECC-System (minimized extracorporeal circulation)\n* informed consent\n\nExclusion Criteria:\n\n* chronic renal insufficiency (serum creatinine \\> 132umol/l)\n* Body Mass Index \\> 35kg/m2\n* additional operative procedures (eg. valve replacement/reconstruction)\n* recent cardiac infarction (\\< 7 days) or elevated cardiac enzymes the day before surgery\n* previous cardiac operation\n* Pregnancy / Lactation\n* known malignant hyperthermia (MH) or known relatives with MH\n* known allergy against propofol, history of propofol infusion syndrome\n* Drug abuse (cocaine, amphetamine, heroine, cannabis)\n* non-judicious persons'}, 'identificationModule': {'nctId': 'NCT01601795', 'briefTitle': 'Sevoflurane and Isoflurane - During Cardiopulmonary Bypass With the MECC System (Minimized Extracorporeal Circuit)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Sevoflurane and Isoflurane - Cardioprotective Effects, Hemodynamic Stability and Pharmacokinetics During Cardiopulmonary Bypass With the MECC System', 'orgStudyIdInfo': {'id': 'BS-57/12'}, 'secondaryIdInfos': [{'id': 'Fassl_57/12', 'type': 'OTHER', 'domain': 'Universityhospital Basel_ANAESTHESIA_FASSL'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sevoflurane', 'description': 'During cardiopulmonary bypass, sevoflurane will be administered through a vaporizer integrated into heart-lung-machine.', 'interventionNames': ['Drug: Sevoflurane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Isoflurane', 'description': 'During cardiopulmonary bypass, isoflurane will be administered through a vaporizer integrated into heart-lung-machine.', 'interventionNames': ['Drug: Isoflurane']}], 'interventions': [{'name': 'Sevoflurane', 'type': 'DRUG', 'otherNames': ['Sevorane'], 'description': 'volatile Anaesthetic, duration during cardiopulmonary bypass', 'armGroupLabels': ['Sevoflurane']}, {'name': 'Isoflurane', 'type': 'DRUG', 'otherNames': ['Isofluran'], 'description': 'volatile anesthetic, duration during cardiopulmonary bypass time', 'armGroupLabels': ['Isoflurane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Jens Fassl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Basel Departement of Anesthesiology and Intensive care medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leipzig', 'class': 'OTHER'}, {'name': 'RWTH Aachen University', 'class': 'OTHER'}, {'name': 'Penn State University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}