Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2026-01-05 @ 12:42 AM
Study NCT ID:
NCT03341169
Status:
UNKNOWN
Last Update Posted:
2019-01-10
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A Randomized, Double-Blinded, Placebo-Controlled Trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-09', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-11-09', 'lastUpdatePostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)', 'timeFrame': '1 day before the operation'}, {'measure': 'degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)', 'timeFrame': '10 minutes after ICU(intensive care unit) entrance,'}, {'measure': 'degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)', 'timeFrame': '24 hours after surgery'}, {'measure': 'degree of myocardial damage with CK-MB (Creatine Kinase MB lsoenzyme)', 'timeFrame': '48 hours after surgery'}, {'measure': 'Troponin-T(Tn-T) level', 'timeFrame': '1 day before the operation'}, {'measure': 'Troponin-T(Tn-T) level', 'timeFrame': '24 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'IL-6', 'timeFrame': 'a day before surgery'}, {'measure': 'IL-6', 'timeFrame': '10 minutes after ICU(intensive care unit) entrance'}, {'measure': 'Free fatty acid', 'timeFrame': 'a day before surgery'}, {'measure': 'Free fatty acid', 'timeFrame': '10 minutes after ICU(intensive care unit) entrance'}, {'measure': 'CRP', 'timeFrame': 'a day before surgery'}, {'measure': 'CRP', 'timeFrame': '24 hours after surgery'}, {'measure': 'cardiovascular index', 'timeFrame': '10 minutes after ICU(intensive care unit) entrance'}, {'measure': 'cardiovascular index', 'timeFrame': '12 hours after surgery'}, {'measure': 'cardiovascular index', 'timeFrame': '24 hours after surgery'}, {'measure': 'occurrence of sternal infections', 'timeFrame': 'Within 30 days postoperatively'}, {'measure': 'mortality', 'timeFrame': 'During hospitalization regardless of length of stay or within 30 days of surgery if discharged'}, {'measure': 'occurrence of cardiovascular complications', 'timeFrame': 'up to 1 year', 'description': '\\*cardiovascular (myocardial infarction, heart failure, arrhythmia), cerebral infarction, renal failure: During the hospitalization for surgery, which includes the entire postoperative period up to discharge, even if over 30 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Aortic Valve Stenois']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to confirm if myocardial protection effect can be obtained by intravenous administration of glutamine in patients undergoing aortic valve replacement with severe aortic stenosis (who are at high risk for ischemia-reperfusion injury). As a prospective double blinded randomized placebo-controlled trial, the investigators detect and compare the degree of myocardial damage(with CK-MB and Troponin T) and myocardial protection (through hsp 70 expression in atrial tissue), cardiovascular index, inflammatory reaction, and clinical manifestation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients with between 20 and 80 years scheduled for aortic valve replacement alone or combined surgery including aortic valve replacement due to severe aortic valve stenosis\n\nExclusion Criteria:\n\n* Patients with renal insufficiency (eGFR 60 ml / min / 1.73 m 2 or less)\n* patients who are considering surgery for coronary artery disease or who have a stenosis\\> 70%\n* hemodynamically unstable patients undergoing emergency surgery or patients with intra-aortic balloon pump insertion\n* patients unable to make their own decisions, illiterate, foreigners\n* epilepsy\n* severe metabolic acidosis\n* pulmonary edema\n* history of myocardial infarction\n* elevation of total bilirubin or AST / ALT\n* Patients higher than normal, weighing more than 80 kg\n* with evidence of infection\n* pregnant and lactating women'}, 'identificationModule': {'nctId': 'NCT03341169', 'briefTitle': 'Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'officialTitle': 'Impact of Perioperative Treatment With Intravenous Glutamine on Myocardial Protection in Cardiac Surgery Patients With Aortic Stenosis', 'orgStudyIdInfo': {'id': '4-2017-0774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glutamine', 'description': 'Intravenous glutamine infusion perioperatively for 18 hours (8 hours before surgery and 10 hours after induction of anesthesia)', 'interventionNames': ['Drug: N(2)-L-Alanine L-Glutamine dipeptide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: placebo (0.9% NaCl (normal saline))']}], 'interventions': [{'name': 'N(2)-L-Alanine L-Glutamine dipeptide', 'type': 'DRUG', 'description': ':Intravenous infusion of N (2) -L-alanyl-L-glutamine(mixed with normal saline, ratio 1:1) at the dose of 0.25g/kg(body weight) for 8 hours before induction of anesthesia(rate=2.5\\*weight/8 ml/h) and administration another 0.25g/kg(body weight) of N (2) -L-alanyl-L-glutamine(mixed with 8.5% amino acid solution, ratio 1:5) into the central vein for 10 hours after induction of anesthesia(rate=0.75\\*weight ml/h)', 'armGroupLabels': ['Glutamine']}, {'name': 'placebo (0.9% NaCl (normal saline))', 'type': 'DRUG', 'description': 'Intravenous infusion of 0.9% NaCl for 8 hours before induction of anesthesia(rate=2.5\\*weight/8 ml/h) and administration 0.9% NaCl into the central vein for 10 hours after induction of anesthesia(rate=0.75\\*weight ml/h)', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03722', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jong Wook Song, MD', 'role': 'CONTACT', 'email': 'SJW72331@yuhs.ac', 'phone': '82-2-2227-3971'}], 'facility': 'Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jong Wook Song, MD', 'role': 'CONTACT', 'email': 'SJW72331@yuhs.ac', 'phone': '82-2-2227-3971'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}