Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-11 @ 1:17 AM
Study NCT ID:
NCT03107858
Status:
UNKNOWN
Last Update Posted:
2017-10-20
First Post:
2017-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009638', 'term': 'Norepinephrine'}, {'id': 'D004298', 'term': 'Dopamine'}], '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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-18', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum creatinine', 'timeFrame': 'four hours postoperatively', 'description': 'postoperative'}], 'secondaryOutcomes': [{'measure': 'blood urea', 'timeFrame': 'four hours postoperatively', 'description': 'postoperative'}, {'measure': 'urine output', 'timeFrame': 'over 24 hours', 'description': 'postoperative'}, {'measure': 'renal artery diameter', 'timeFrame': 'four hours postoperatively', 'description': 'Measured postoperative through renal artery Doppler'}, {'measure': 'renal artery blood flow', 'timeFrame': 'four hours postoperatively', 'description': 'Measured postoperative through renal artery Doppler'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Renal Transplant']}, 'descriptionModule': {'briefSummary': 'Renal transplantation is now recognized as a treatment of choice for patients with chronic renal failure with end-stage renal disease. Renal transplantations are associated with better quality of life, better cost/benefit ratio, and possibly longer survival. Significant changes in blood pressure are common throughout the surgical procedure for kidney transplantation. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration. All efforts are made to maintain an appropriate level of blood pressure by using an adequate intravascular volume and vasopressor administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients scheduled for a living donor kidney transplantation\n\nExclusion Criteria:\n\n* Patients (less than 18 years old)\n* Patients' refusal of consenting for enrolment in the study"}, 'identificationModule': {'nctId': 'NCT03107858', 'briefTitle': 'The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Effect of Norepinephrine Versus Dopamine in Renal Transplant Recipients on Postoperative Graft Function', 'orgStudyIdInfo': {'id': 'NorepivsDopamine'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Norepinephrine', 'interventionNames': ['Drug: Norepinephrine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dopamine', 'interventionNames': ['Drug: Dopamine']}], 'interventions': [{'name': 'Norepinephrine', 'type': 'DRUG', 'description': 'Norepinephrine infusion will be used at a starting dose of 0.05μg/kg/min. Dose range: 0.05 -0.15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative', 'armGroupLabels': ['Norepinephrine']}, {'name': 'Dopamine', 'type': 'DRUG', 'description': 'Dopamine infusion will be used at a starting dose of 5μg/kg/min. Dose range: 5 -15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative', 'armGroupLabels': ['Dopamine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmed Elkadi', 'role': 'CONTACT', 'phone': '01007485190'}], 'facility': 'Assiut University Hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Ahmed Elkadi, MBBC', 'role': 'CONTACT', 'email': 'ahmedkader333@gmail.com', 'phone': '+201007485190'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Ahmed Abdel Kader Ahmed Mohammed Elkadi', 'investigatorAffiliation': 'Assiut University'}}}}