Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2025-12-24 @ 3:01 PM
Study NCT ID:
NCT04558359
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2020-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Renin and Renal Biomarker Response to Angiotensin II
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D000804', 'term': 'Angiotensin II'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'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': 'alexander.flannery@gmail.com', 'phone': '859-562-2766', 'title': 'Alexander Flannery, PharmD, PhD', 'organization': 'University of Kentucky'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 72 hours following shock resolution, no longer than 17 days from enrollment', 'description': 'Targeted screening for venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection from enrollment up to 72 hours following shock resolution.', 'eventGroups': [{'id': 'EG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 9, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 9, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Plasma Renin Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'title': 'Baseline Minus 24-Hour Sample', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-15', 'groupId': 'OG000', 'lowerLimit': '-291', 'upperLimit': '38'}, {'value': '69', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '352'}]}]}, {'title': 'Baseline Minus Shock Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6', 'groupId': 'OG000', 'lowerLimit': '-101', 'upperLimit': '372'}, {'value': '26', 'groupId': 'OG001', 'lowerLimit': '13', 'upperLimit': '340'}]}]}, {'title': 'Baseline Minus 3-Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '292'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was only done in the angiotensin II arm.'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Cystatin C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'title': 'Baseline Minus 24-Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-254', 'groupId': 'OG000', 'lowerLimit': '-731', 'upperLimit': '932'}, {'value': '-143', 'groupId': 'OG001', 'lowerLimit': '-762', 'upperLimit': '121'}]}]}, {'title': 'Baseline Minus Shock Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000', 'lowerLimit': '-920', 'upperLimit': '815'}, {'value': '-124', 'groupId': 'OG001', 'lowerLimit': '-524', 'upperLimit': '644'}]}]}, {'title': 'Baseline Minus 3-Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-196', 'groupId': 'OG001', 'lowerLimit': '-527', 'upperLimit': '329'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'Cystatin C will be measured from blood collected at baseline, 24 hours, and at shock resolution.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was done only in the angiotensin II arm.'}, {'type': 'SECONDARY', 'title': 'Days to Discontinuation of Catecholamines', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '3.2'}, {'value': '3.5', 'groupId': 'OG001', 'lowerLimit': '1.3', 'upperLimit': '6.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until shock resolution, up to 14 days', 'description': 'Days from enrollment to discontinuation of catecholamines', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '8.5'}, {'value': '7.2', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '11.5'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From enrollment to ICU discharge, up to 28 days following enrollment', 'description': 'Number of days in the intensive care unit (ICU).', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With In-hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 3 months following enrollment', 'description': 'Assessment of all-cause mortality within hospital admission', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Renal Replacement Therapy-free Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '0'}, {'value': '21', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '28'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Within 28 days of enrollment', 'description': 'Days free of renal replacement therapy from enrollment up to day 28', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Experiencing Prespecified Safety Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 72 hours following shock resolution, no longer than 17 days from enrollment', 'description': 'Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'OG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'classes': [{'title': 'Baseline Minus 24-Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '-13', 'upperLimit': '213'}, {'value': '93', 'groupId': 'OG001', 'lowerLimit': '-39', 'upperLimit': '235'}]}]}, {'title': 'Baseline Minus Shock Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000', 'lowerLimit': '-39', 'upperLimit': '819'}, {'value': '201', 'groupId': 'OG001', 'lowerLimit': '66', 'upperLimit': '421'}]}]}, {'title': 'Baseline Minus 3-Hour', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-21', 'groupId': 'OG001', 'lowerLimit': '-75', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Number analyzed in one or more rows may be different from overall number due to participant death which would preclude subsequent measurements. 3-hour sample was only done in the angiotensin II arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'FG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': '2 enrolled participants in the angiotensin II arm had changes in status that deemed them ineligible for the study and they subsequently did not receive open label angiotensin II.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.\n\nStandard of Care: These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'BG001', 'title': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.\n\nAngiotensin II: These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '66'}, {'value': '61', 'groupId': 'BG001', 'lowerLimit': '48', 'upperLimit': '69'}, {'value': '62', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '66'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-03-19', 'size': 3677848, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-07-23T11:19', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2020-09-07', 'resultsFirstSubmitDate': '2024-07-23', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-14', 'studyFirstPostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Plasma Renin Levels', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'Plasma renin levels will be measured from blood collected at baseline, 24 hours, and at shock resolution. Additionally, a 3-hour measurement will be included in the angiotensin II arm.'}], 'secondaryOutcomes': [{'measure': 'Change in Plasma Cystatin C', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'Cystatin C will be measured from blood collected at baseline, 24 hours, and at shock resolution.'}, {'measure': 'Days to Discontinuation of Catecholamines', 'timeFrame': 'Until shock resolution, up to 14 days', 'description': 'Days from enrollment to discontinuation of catecholamines'}, {'measure': 'ICU Length of Stay', 'timeFrame': 'From enrollment to ICU discharge, up to 28 days following enrollment', 'description': 'Number of days in the intensive care unit (ICU).'}, {'measure': 'Number of Participants With In-hospital Mortality', 'timeFrame': 'Up to 3 months following enrollment', 'description': 'Assessment of all-cause mortality within hospital admission'}, {'measure': 'Renal Replacement Therapy-free Days', 'timeFrame': 'Within 28 days of enrollment', 'description': 'Days free of renal replacement therapy from enrollment up to day 28'}, {'measure': 'Number of Participants Experiencing Prespecified Safety Outcomes', 'timeFrame': 'Up to 72 hours following shock resolution, no longer than 17 days from enrollment', 'description': 'Incidence of venous thromboembolism, arrhythmia, extremity hypoperfusion, delirium, new ischemic event, new infection'}, {'measure': 'Change in Plasma Neutrophil Gelatinase-associated Lipocalin (NGAL)', 'timeFrame': 'Until shock resolution, up to 14 days (at baseline, 3 hours, 24 hours, and shock resolution, up to 14 days)', 'description': 'NGAL will be measured from blood collected at baseline, 24 hours, and at shock resolution.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renin', 'Angiotensin II', 'vasopressor', 'sepsis'], 'conditions': ['Septic Shock', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Septic shock continues to exert a large economic burden around the world. Several developments have occurred that lead to the current study. First, angiotensin II is the newest FDA approved vasopressor agent indicated for use in vasodilatory shock. Several subgroups from the approval trial have indicated that angiotensin II may confer a survival benefit in certain conditions, including those patients requiring continuous renal replacement therapy, those with altered angiotensin I: angiotensin II ratios, and most recently, those with elevated renin levels (which may serve as a surrogate for dysfunctional angiotensin 1: angiotensin II ratios). This open-label, sequential period pilot study will evaluate angiotensin II and biomarker response (renin) in the treatment of septic shock.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical ICU admission\n* Septic shock\n* Norepinephrine requirement = 0.15 mcg/kg/min for = 30 minutes (if cirrhosis, norepinephrine requirement = 0.1 mcg/kg/min for = 30 minutes)\n* Kidney Disease Improving Global Outcomes stage 1 or greater Acute Kidney Injury\n\nExclusion Criteria:\n\n* Prisoner\n* Pregnancy\n* Acute occlusive coronary syndrome requiring intervention or acute myocardial infarction of any degree\n* Purely cardiogenic shock (no distributive component)\n* Mesenteric ischemia\n* Acute ischemic stroke\n* Hemorrhagic shock\n* Active treatment of hepatorenal syndrome targeting a Mean Arterial Pressure = 65 mm Hg\n* Planned withdrawal of care within next 24 hours or no escalation of care\n* Patient enrolled in an interventional study\n* High likelihood of medical futility in using this drug:\n* 3 or more vasopressors required to sustain MAP\n* Sustained norepinephrine equivalents \\> 0.5 mcg/kg/min\n* COVID-19 positive, or high suspicion of COVID-19'}, 'identificationModule': {'nctId': 'NCT04558359', 'briefTitle': 'Renin and Renal Biomarker Response to Angiotensin II', 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': 'Renin and Renal Biomarker Response to Angiotensin II Versus Controls in Septic Shock: An Open-Label Study', 'orgStudyIdInfo': {'id': '57411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard of Care Cohort', 'description': 'Patients in this group will receive standard of care treatment.', 'interventionNames': ['Other: Standard of Care']}, {'type': 'EXPERIMENTAL', 'label': 'Angiotensin II Cohort', 'description': 'Patients in this group will receive angiotensin II.', 'interventionNames': ['Drug: Angiotensin II']}], 'interventions': [{'name': 'Standard of Care', 'type': 'OTHER', 'description': 'These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.', 'armGroupLabels': ['Standard of Care Cohort']}, {'name': 'Angiotensin II', 'type': 'DRUG', 'description': 'These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.', 'armGroupLabels': ['Angiotensin II Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky HealthCare Chandler Medical Center', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Alexander H Flannery, Pharm.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexander Flannery', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Alexander Flannery', 'investigatorAffiliation': 'University of Kentucky'}}}}