Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-03-11 @ 6:51 AM
Study NCT ID:
NCT01669434
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2012-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery
Sponsor:
Organization:
Raw JSON
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'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Acute Renal Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '119', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACEI Omission', 'description': 'Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.'}, {'id': 'OG001', 'title': 'ACEI Continuation', 'description': 'Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI continuation: These chronic medications will be given without interruption preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.44', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.60', 'ciLowerLimit': '0.23', 'ciUpperLimit': '1.60', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.', 'description': 'Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Missing outcome data for 37 patients, 18 in the ACEI omission arm and 19 in the ACEI continuation arm'}, {'type': 'SECONDARY', 'title': 'Low Blood Pressure Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 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'2.99', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During anesthesia, an expected average of 3 hours.', 'description': 'Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. 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medications will be given without interruption preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.01', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.95', 'ciLowerLimit': '1.14', 'ciUpperLimit': '3.34', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Arrival in PACU to hospital discharge, an expected average of 4 days.', 'description': 'Any systolic blood pressure greater than 180 mmHg.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Hypotension', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ACEI Omission', 'description': 'Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.'}, {'id': 'OG001', 'title': 'ACEI Continuation', 'description': 'Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI continuation: These chronic medications will be given without interruption preoperatively.'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.02', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Ratio (RR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.49', 'ciLowerLimit': '0.28', 'ciUpperLimit': '0.86', 'statisticalMethod': 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without interruption preoperatively.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '137'}, {'groupId': 'FG001', 'numSubjects': '138'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ACEI Omission', 'description': 'Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or evening before surgery, whenever the last preoperative dose would normally occur.'}, {'id': 'BG001', 'title': 'ACEI Continuation', 'description': 'Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose.\n\nACEI continuation: These chronic medications will be given without interruption preoperatively.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '26', 'upperLimit': '91'}, {'value': '63.7', 'groupId': 'BG001', 'lowerLimit': '31', 'upperLimit': '86'}, {'value': '63.9', 'groupId': 'BG002', 'lowerLimit': '26', 'upperLimit': '91'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '142', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '65', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '115', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Am Indian/Alaska', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Other/Unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '137', 'groupId': 'BG000'}, {'value': '138', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'smoking status', 'classes': [{'categories': [{'title': 'Never', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '117', 'groupId': 'BG002'}]}, {'title': 'Former', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '119', 'groupId': 'BG002'}]}, {'title': 'Current', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'American Society of Anesthesiologists classification', 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'BG000', 'lowerLimit': '1', 'upperLimit': '4'}, {'value': '2.8', 'groupId': 'BG001', 'lowerLimit': '2', 'upperLimit': '4'}, {'value': '2.8', 'groupId': 'BG002', 'lowerLimit': '1', 'upperLimit': '4'}]}]}], 'paramType': 'MEAN', 'description': 'Scale range 1-6 I A normal healthy patient Healthy, non-smoking, no or minimal alcohol use 2 A patient with mild systemic disease 3 A patient with severe systemic disease 4 A patient with severe systemic disease that is a constant threat to life 5 A moribund patient who is not expected to survive without the operation 6 A declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'FULL_RANGE'}, {'title': 'preoperative NSAID use', 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '124', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'preoperative systolic BP', 'classes': [{'categories': [{'measurements': [{'value': '136.6', 'groupId': 'BG000', 'lowerLimit': '99', 'upperLimit': '187'}, {'value': '136.3', 'groupId': 'BG001', 'lowerLimit': '102', 'upperLimit': '184'}, {'value': '136.5', 'groupId': 'BG002', 'lowerLimit': '99', 'upperLimit': '187'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'FULL_RANGE'}, {'title': 'hypertension history', 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'congestive heart failure history', 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Additional antihypertensive', 'classes': [{'categories': [{'measurements': [{'value': '92', 'groupId': 'BG000'}, {'value': '95', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Use of at least one additional antihypertensive medication in addition to an angiotensin converting enzyme inhibitor at the time of enrollment.', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 291}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-02', 'studyFirstSubmitDate': '2012-08-14', 'resultsFirstSubmitDate': '2017-10-09', 'studyFirstSubmitQcDate': '2012-08-16', 'lastUpdatePostDateStruct': {'date': '2023-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-08', 'studyFirstPostDateStruct': {'date': '2012-08-21', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Interoperative Hypotension', 'timeFrame': 'During anesthesia, an expected average of 3 hours.', 'description': 'Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg)'}], 'secondaryOutcomes': [{'measure': 'Acute Renal Failure', 'timeFrame': 'Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days.', 'description': 'Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level'}, {'measure': 'Low Blood Pressure Subgroup', 'timeFrame': 'During anesthesia, an expected average of 3 hours.', 'description': 'Only patients with systolic blood pressure less than 110 at preoperative evaluation will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg.'}, {'measure': 'Older Age Subgroup', 'timeFrame': 'During anesthesia, an expected average of 3 hours.', 'description': 'Only patients above the age of 64 will be included in this analysis. The outcome is the same as the primary outcome: Intraoperative Systolic Blood Pressure under 80 mmHg'}, {'measure': 'Postoperative Hypertension', 'timeFrame': 'Arrival in PACU to hospital discharge, an expected average of 4 days.', 'description': 'Any systolic blood pressure greater than 180 mmHg.'}, {'measure': 'Postoperative Hypotension', 'timeFrame': 'Arrival in PACU to hospital discharge, an expected average of 4 days.', 'description': 'Any systolic blood pressure less than 90 mmHg'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Perioperative Period'], 'conditions': ['Hypotension on Induction']}, 'referencesModule': {'references': [{'pmid': '2692007', 'type': 'BACKGROUND', 'citation': 'McConachie I, Healy TE. ACE inhibitors and anaesthesia. Postgrad Med J. 1989 May;65(763):273-4. doi: 10.1136/pgmj.65.763.273. No abstract available.'}, {'pmid': '8053578', 'type': 'BACKGROUND', 'citation': 'Coriat P, Richer C, Douraki T, Gomez C, Hendricks K, Giudicelli JF, Viars P. Influence of chronic angiotensin-converting enzyme inhibition on anesthetic induction. Anesthesiology. 1994 Aug;81(2):299-307. doi: 10.1097/00000542-199408000-00006.'}, {'pmid': '15728043', 'type': 'BACKGROUND', 'citation': 'Comfere T, Sprung J, Kumar MM, Draper M, Wilson DP, Williams BA, Danielson DR, Liedl L, Warner DO. Angiotensin system inhibitors in a general surgical population. Anesth Analg. 2005 Mar;100(3):636-644. doi: 10.1213/01.ANE.0000146521.68059.A1.'}, {'pmid': '10690132', 'type': 'BACKGROUND', 'citation': 'Pigott DW, Nagle C, Allman K, Westaby S, Evans RD. Effect of omitting regular ACE inhibitor medication before cardiac surgery on haemodynamic variables and vasoactive drug requirements. Br J Anaesth. 1999 Nov;83(5):715-20. doi: 10.1093/bja/83.5.715.'}, {'pmid': '28722845', 'type': 'BACKGROUND', 'citation': 'Steiner CA, Karaca Z, Moore BJ, Imshaug MC, Pickens G. Surgeries in Hospital-Based Ambulatory Surgery and Hospital Inpatient Settings, 2014. 2017 May [updated 2020 Jul 20]. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #223. Available from http://www.ncbi.nlm.nih.gov/books/NBK442035/'}, {'type': 'BACKGROUND', 'citation': 'Rate of all-listed procedures for discharges from short-stay hospitals, by procedure category and age: United States, 2010. 2010.'}, {'pmid': '22253266', 'type': 'BACKGROUND', 'citation': 'Turan A, You J, Shiba A, Kurz A, Saager L, Sessler DI. Angiotensin converting enzyme inhibitors are not associated with respiratory complications or mortality after noncardiac surgery. Anesth Analg. 2012 Mar;114(3):552-60. doi: 10.1213/ANE.0b013e318241f6af. Epub 2012 Jan 17.'}, {'pmid': '25929547', 'type': 'BACKGROUND', 'citation': 'Mascha EJ, Yang D, Weiss S, Sessler DI. Intraoperative Mean Arterial Pressure Variability and 30-day Mortality in Patients Having Noncardiac Surgery. Anesthesiology. 2015 Jul;123(1):79-91. doi: 10.1097/ALN.0000000000000686.'}, {'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.'}, {'pmid': '11133595', 'type': 'BACKGROUND', 'citation': 'Bertrand M, Godet G, Meersschaert K, Brun L, Salcedo E, Coriat P. Should the angiotensin II antagonists be discontinued before surgery? Anesth Analg. 2001 Jan;92(1):26-30. doi: 10.1097/00000539-200101000-00006.'}, {'pmid': '27775997', 'type': 'BACKGROUND', 'citation': 'Roshanov PS, Rochwerg B, Patel A, Salehian O, Duceppe E, Belley-Cote EP, Guyatt GH, Sessler DI, Le Manach Y, Borges FK, Tandon V, Worster A, Thompson A, Koshy M, Devereaux B, Spencer FA, Sanders RD, Sloan EN, Morley EE, Paul J, Raymer KE, Punthakee Z, Devereaux PJ. Withholding versus Continuing Angiotensin-converting Enzyme Inhibitors or Angiotensin II Receptor Blockers before Noncardiac Surgery: An Analysis of the Vascular events In noncardiac Surgery patIents cOhort evaluatioN Prospective Cohort. 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Prospective Randomized Evaluation of Preoperative Angiotensin-Converting Enzyme Inhibition (PREOP-ACEI). J Hosp Med. 2018 Sep;13(10):661-667. doi: 10.12788/jhm.3036. Epub 2018 Jul 25.'}]}, 'descriptionModule': {'briefSummary': 'Primary research hypothesis: Patients who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.\n\nSecondary research hypothesis #1: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience better postoperative control of hypertension than those who transiently hold their chronic ACEI preoperatively.\n\nSecondary research hypothesis #2: Patients who continue their chronic ACEI up to and including the morning of a non-cardiac, non-vascular surgery will experience less acute renal failure than those who transiently hold their chronic ACEI preoperatively.\n\nSecondary research hypothesis #3: In the subgroup of patients with a preoperative systolic blood pressure less than 110 mmHg, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.\n\nSecondary research hypothesis #4: In the subgroup of patients above the age of 64, those who continue their chronic ACEI therapy up to and including the morning of a non-cardiac, non-vascular surgery will experience more intraoperative hypotension than those who transiently hold their chronic ACEI preoperatively.', 'detailedDescription': 'The purpose of this study is to determine if transient discontinuation of angiotensin converting enzyme inhibitors (ACEIs) is necessary prior to non-cardiac, non-vascular surgery. ACEIs have been associated with intraoperative hypotension during vascular and cardiac surgeries. Patients presenting to the University of Nebraska Medical Center Pre-Anesthesia Screening (PAS) Clinic who are on chronic ACEI therapy will be eligible for enrollment. Subjects will be randomized to either omit or continue their ACEI preoperatively. The outcome of interest is intraoperative hypotension defined as a systolic blood pressure less than 80 mmHg. Blood pressure will be followed not only throughout surgery, but also during recovery and the remainder of hospitalization. Renal function will be assessed with creatinine measurements in the PAS clinic and on the first postoperative day. No follow-up is planned beyond discharge from the hospital.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred to the University of Nebraska Medical Center Pre-Anesthesia Screening Clinic for preoperative evaluation.\n* Above referral must be in anticipation of a non-cardiac, non-vascular surgery.\n* Must have been on ACE-Inhibitor therapy for at least six weeks.\n\nExclusion Criteria:\n\n* Hypotension (systolic blood pressure \\< 90 or diastolic blood pressure \\<60) at the time of preoperative evaluation\n* Uncontrolled Hypertension (systolic blood pressure \\> 150 or diastolic blood pressure \\> 95) at the time of preoperative evaluation\n* Surgery during which vasopressor use is anticipated (carotid endarterectomy, major abdominal operations, orthopedic oncology)\n* Surgery for pathology related to vasoactive substances (carcinoid, pheochromocytoma)\n* Left Ventricular ejection fraction less than 40%\n* Clinical evidence of decompensated heart failure at the time of preoperative evaluation\n* End-stage renal disease\n* Organ transplant surgeries'}, 'identificationModule': {'nctId': 'NCT01669434', 'briefTitle': 'Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Chronic Angiotensin Converting Enzyme Inhibitors in Intermediate Risk Surgery: A Randomized, Single-Blinded Study', 'orgStudyIdInfo': {'id': '0369-12-FB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ACEI continuation', 'description': 'Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively', 'interventionNames': ['Drug: ACEI continuation']}, {'type': 'EXPERIMENTAL', 'label': 'ACEI omission', 'description': 'Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose.', 'interventionNames': ['Drug: ACEI omission']}], 'interventions': [{'name': 'ACEI continuation', 'type': 'DRUG', 'otherNames': ['quinapril', 'Accupril', 'perindopril', 'Aceon', 'ramipril', 'Altace', 'benazepril', 'Lotensin', 'captopril', 'Capoten', 'enalapril', 'Vasotec', 'fosinopril', 'Monopril', 'lisinopril', 'Prinivil', 'Zestril', 'trandolapril', 'Mavik', 'moexipril', 'Univasc'], 'description': 'These chronic medications will be taken without interruption preoperatively.', 'armGroupLabels': ['ACEI continuation']}, {'name': 'ACEI omission', 'type': 'DRUG', 'otherNames': ['quinapril', 'Accupril', 'perindopril', 'Aceon', 'ramipril', 'Altace', 'benazepril', 'Lotensin', 'captopril', 'Capoten', 'enalapril', 'Vasotec', 'fosinopril', 'Monopril', 'lisinopril', 'Prinivil', 'Zestril', 'trandolapril', 'Mavik', 'moexipril', 'Univasc'], 'description': 'Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.', 'armGroupLabels': ['ACEI omission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Jason F Shiffermiller, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}