Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
Study NCT ID:
NCT04431492
Status:
UNKNOWN
Last Update Posted:
2020-07-14
First Post:
2020-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Anaesthesia on Basic Aminoacids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 58}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-11', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-11', 'lastUpdatePostDateStruct': {'date': '2020-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'basic aminoacids and NO levels', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Effect of Anaesthesia on Basic Aminoacids']}, 'descriptionModule': {'briefSummary': 'Basic amino acids are acids that contains amino groups more than carboxylic groups. At least five basic amino acids namely; Arginine, citrulline, ornithine, lysine and hydroxylysine metabolize in our body. Loss of body protein represents a typical feature of the catabolic response to surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients undergoing cardiopulmonary bypass and thoracotomy for lung resection secondary to lung carcinoma, three samples will be taken to evaluate the levels of basic amino acids and NO levels', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective surgery\n* ASA II,III\n\nExclusion Criteria:\n\n* Emergency surgery\n* Associated renal or liver disease\n* Chronic disease as D.M'}, 'identificationModule': {'nctId': 'NCT04431492', 'briefTitle': 'Effect of Anaesthesia on Basic Aminoacids', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Anaesthesia and Surgery on Plasma Levels of Nitric Oxide and Basic Aminoacids', 'orgStudyIdInfo': {'id': '13700418'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'coronary artery bypass', 'interventionNames': ['Procedure: CABG']}, {'label': 'thoracic surgery'}], 'interventions': [{'name': 'CABG', 'type': 'PROCEDURE', 'description': 'aminoacids and NO levels', 'armGroupLabels': ['coronary artery bypass']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'rasha hamed, MD', 'role': 'CONTACT', 'email': 'rashaahmed11@yahoo.nom', 'phone': '0882413201'}], 'facility': 'Assiut university', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'saeid elsawy', 'role': 'CONTACT', 'email': 'saeedelsawy17@gmail.com', 'phone': '01030072161'}, {'name': 'Ali', 'role': 'CONTACT', 'email': 'rashaahmed7272@gmail.com', 'phone': '01030072161'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer of anaesthesia', 'investigatorFullName': 'Rasha Hamed', 'investigatorAffiliation': 'Assiut University'}}}}