Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT04529005
Status:
COMPLETED
Last Update Posted:
2022-12-21
First Post:
2020-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012773', 'term': 'Shock, Surgical'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007022', 'term': 'Hypotension'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000804', 'term': 'Angiotensin II'}], 'ancestors': [{'id': 'D000809', 'term': 'Angiotensins'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'benken@uic.edu', 'phone': '3123554107', 'title': 'Scott Benken', 'organization': 'University of Illinois Chicago College of Pharmacy'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '30 days', 'eventGroups': [{'id': 'EG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Thrombocytopenia', 'notes': 'defined as platelet count \\<50,000', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Duration of ATII Vasopressor Usage in the Intraoperative Setting', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Duration of usage during the transplant surgery - presented in hours', 'description': 'Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Started ATII intraoperatively'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Arrhythmias', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Peripheral/Visceral Ischemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Fungal Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Hyperglycemia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number (and Percentage) of Patients With Delayed Graft Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From post-op to 7 days post-op', 'description': 'The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'Angiotensin II: If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Angiotensin II (Giapreza)', 'description': 'The study group received angiotensin II (Giapreza) as the first continuous infusion vasopressor as clinically indicated for either intraoperative or postoperative hypotension not responsive to fluids or push dose vasopressors (intraoperative only).'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56.3', 'spread': '10.7', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-06-01', 'size': 434723, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-26T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-26', 'studyFirstSubmitDate': '2020-08-14', 'resultsFirstSubmitDate': '2022-10-31', 'studyFirstSubmitQcDate': '2020-08-24', 'lastUpdatePostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-11-26', 'studyFirstPostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of ATII Vasopressor Usage in the Intraoperative Setting', 'timeFrame': 'Duration of usage during the transplant surgery - presented in hours', 'description': 'Duration of vasopressor usage while in the operating room measured in hours of usage presented as median and IQR.'}], 'secondaryOutcomes': [{'measure': 'Number (and Percentage) of Patients With Arrhythmias', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of arrhythmia was confirmed via EKG, flowsheet, or note documentation from the electronic medical record.'}, {'measure': 'Number (and Percentage) of Patients With Peripheral/Visceral Ischemia', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of digital or other peripheral/visceral ischemia was captured from reviewing chart documentation for each patient.'}, {'measure': 'Number (and Percentage) of Patients With Thrombosis', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'Incidence of venous or arterial thrombosis occurring during the hospitalization for kidney transplant (captured by ultrasound or other diagnostic imaging)'}, {'measure': 'Number (and Percentage) of Patients With Fungal Infections', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of post-operative fungal infections were captured prior to discharge as documented by the clinical care team in the electronic medical record.'}, {'measure': 'Number (and Percentage) of Patients With Hyperglycemia', 'timeFrame': 'From date and time of study drug initiation during or after transplant operation until study drug is discontinued up to a maximum of 30 days.', 'description': 'The presence of hyperglycemia was captured for each patient and was determined by those patients requiring the use of an insulin infusion after their transplant surgery.'}, {'measure': 'Number (and Percentage) of Patients With Delayed Graft Function', 'timeFrame': 'From post-op to 7 days post-op', 'description': 'The presence of Delayed Graft Function was captured for each patient and defined by the need for renal replacement therapy up to 7 days post-operative.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shock, Surgical', 'Shock', 'Hypotension and Shock', 'Kidney Transplant; Complications', 'Intraoperative Hypotension', 'Postoperative Hypotension']}, 'referencesModule': {'references': [{'pmid': '25948896', 'type': 'BACKGROUND', 'citation': 'Aulakh NK, Garg K, Bose A, Aulakh BS, Chahal HS, Aulakh GS. Influence of hemodynamics and intra-operative hydration on biochemical outcome of renal transplant recipients. J Anaesthesiol Clin Pharmacol. 2015 Apr-Jun;31(2):174-9. doi: 10.4103/0970-9185.155144.'}, {'pmid': '31514910', 'type': 'BACKGROUND', 'citation': 'Busse LW, Ostermann M. Vasopressor Therapy and Blood Pressure Management in the Setting of Acute Kidney Injury. Semin Nephrol. 2019 Sep;39(5):462-472. doi: 10.1016/j.semnephrol.2019.06.006.'}, {'pmid': '22841277', 'type': 'BACKGROUND', 'citation': 'Campos L, Parada B, Furriel F, Castelo D, Moreira P, Mota A. Do intraoperative hemodynamic factors of the recipient influence renal graft function? Transplant Proc. 2012 Jul-Aug;44(6):1800-3. doi: 10.1016/j.transproceed.2012.05.042.'}, {'pmid': '24768292', 'type': 'BACKGROUND', 'citation': 'Day KM, Beckman RM, Machan JT, Morrissey PE. Efficacy and safety of phenylephrine in the management of low systolic blood pressure after renal transplantation. J Am Coll Surg. 2014 Jun;218(6):1207-13. doi: 10.1016/j.jamcollsurg.2014.01.058. Epub 2014 Mar 12.'}, {'pmid': '28072739', 'type': 'BACKGROUND', 'citation': 'Choi JM, Jo JY, Baik JW, Kim S, Kim CS, Jeong SM. Risk factors and outcomes associated with a higher use of inotropes in kidney transplant recipients. Medicine (Baltimore). 2017 Jan;96(1):e5820. doi: 10.1097/MD.0000000000005820.'}, {'pmid': '20005360', 'type': 'BACKGROUND', 'citation': 'Ciapetti M, di Valvasone S, di Filippo A, Cecchi A, Bonizzoli M, Peris A. Low-dose dopamine in kidney transplantation. Transplant Proc. 2009 Dec;41(10):4165-8. doi: 10.1016/j.transproceed.2009.08.058.'}, {'pmid': '28528561', 'type': 'BACKGROUND', 'citation': 'Khanna A, English SW, Wang XS, Ham K, Tumlin J, Szerlip H, Busse LW, Altaweel L, Albertson TE, Mackey C, McCurdy MT, Boldt DW, Chock S, Young PJ, Krell K, Wunderink RG, Ostermann M, Murugan R, Gong MN, Panwar R, Hastbacka J, Favory R, Venkatesh B, Thompson BT, Bellomo R, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Deane AM; ATHOS-3 Investigators. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017 Aug 3;377(5):419-430. doi: 10.1056/NEJMoa1704154. Epub 2017 May 21.'}, {'pmid': '29077618', 'type': 'BACKGROUND', 'citation': 'Lankadeva YR, Kosaka J, Evans RG, Bellomo R, May CN. Urinary Oxygenation as a Surrogate Measure of Medullary Oxygenation During Angiotensin II Therapy in Septic Acute Kidney Injury. Crit Care Med. 2018 Jan;46(1):e41-e48. doi: 10.1097/CCM.0000000000002797.'}, {'pmid': '20381298', 'type': 'BACKGROUND', 'citation': 'Robert R, Guilhot J, Pinsard M, Longeard PL, Jacob JP, Gissot V, Hauet T, Seguin F. A pair analysis of the delayed graft function in kidney recipient: the critical role of the donor. J Crit Care. 2010 Dec;25(4):582-90. doi: 10.1016/j.jcrc.2010.02.011. Epub 2010 Apr 8.'}, {'pmid': '9850443', 'type': 'BACKGROUND', 'citation': "Toth M, Reti V, Gondos T. Effect of recipients' peri-operative parameters on the outcome of kidney transplantation. Clin Transplant. 1998 Dec;12(6):511-7."}, {'pmid': '29509568', 'type': 'BACKGROUND', 'citation': 'Tumlin JA, Murugan R, Deane AM, Ostermann M, Busse LW, Ham KR, Kashani K, Szerlip HM, Prowle JR, Bihorac A, Finkel KW, Zarbock A, Forni LG, Lynch SJ, Jensen J, Kroll S, Chawla LS, Tidmarsh GF, Bellomo R; Angiotensin II for the Treatment of High-Output Shock 3 (ATHOS-3) Investigators. Outcomes in Patients with Vasodilatory Shock and Renal Replacement Therapy Treated with Intravenous Angiotensin II. Crit Care Med. 2018 Jun;46(6):949-957. doi: 10.1097/CCM.0000000000003092.'}, {'pmid': '23835589', 'type': 'BACKGROUND', 'citation': 'Walsh M, Devereaux PJ, Garg AX, Kurz A, Turan A, Rodseth RN, Cywinski J, Thabane L, Sessler DI. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension. Anesthesiology. 2013 Sep;119(3):507-15. doi: 10.1097/ALN.0b013e3182a10e26.'}]}, 'descriptionModule': {'briefSummary': 'The current standard of catecholamine vasopressor management of perioperative hypotension in kidney transplant patients carries significant risks and falls short in many ways. Currently, there is an absence in the scientific literature and research describing the hemodynamic effectiveness and safety of novel pharmacologic agents such as angiotensin II (Giapreza - Ang II) in perioperative kidney transplant patients. Phase 3 registration trials have demonstrated the superior safety and efficacy of Ang II (Giapreza) in distributive shock patients compared to traditional vasopressor agents and the novel mechanism of action may provide additional protection in renal transplant patients. The pilot study entails giving informed and consenting kidney transplant recipients Ang II (Giapreza) as their first vasopressor if the need for vasopressors emerge either intraoperatively or postoperatively in kidney transplant recipients. The primary objective is to evaluate the safety and hemodynamic effects of Ang II (Giapreza) in the renal transplant population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult patients \\> 18 years of age\n* Receiving deceased donor kidney transplant\n* Pre-transplant Ejection Fraction (within past 18 months) \\> 50%\n* Intraoperative or postoperative distributive shock (according to hospital and study protocol) requiring vasopressor support\n\nExclusion Criteria:\n\n* Pregnant patients (they would be excluded from receiving a transplant)\n* Prisoners\n* History of mesenteric ischemia\n* History of aortic dissection\n* History of abdominal aortic aneurysm\n* Allergy to mannitol\n* Absolute neutrophil count \\< 1000 cell/mm3 (within past 18 months)\n* Diagnosis of Raynaud's phenomenon, systemic sclerosis or vasospastic disease"}, 'identificationModule': {'nctId': 'NCT04529005', 'briefTitle': 'Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Angiotensin II in the Perioperative Management of Hypotension in Kidney Transplant', 'orgStudyIdInfo': {'id': '2020-0526'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Angiotensin II (Giapreza)', 'interventionNames': ['Drug: Angiotensin II']}], 'interventions': [{'name': 'Angiotensin II', 'type': 'DRUG', 'description': 'If intraoperative or postoperative hypotension occurs (e.g. SBP \\< 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.', 'armGroupLabels': ['Angiotensin II (Giapreza)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois Hospital and Health Sciences System', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Scott T Benken, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Associate Professor'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'La Jolla Pharmaceutical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Associate Professor', 'investigatorFullName': 'Scott Benken', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}