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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.
Secondary 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.
Secondary 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.
Secondary 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.
Secondary 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACEI continuation | Experimental | Patients in this arm will be randomized to continue their chronic angiotensin converting enzyme inhibitor without interruption preoperatively |
|
| ACEI omission | Experimental | Patients randomized to this arm will be told to omit their final preoperative chronic angiotensin converting enzyme inhibitor dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACEI continuation | Drug | These chronic medications will be taken without interruption preoperatively. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Interoperative Hypotension | Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg) | During anesthesia, an expected average of 3 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Renal Failure | Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level | Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days. |
| Low Blood Pressure Subgroup |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason F Shiffermiller, MD, MPH | University of Nebraska | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 2692007 | Background | 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. | |
| 8053578 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | ACEI Omission | Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose. ACEI omission: These medications, although taken chronically by patients in this intervention, will not be given on the morning of surgery or day before surgery, whenever the last preoperative dose would normally occur. |
| FG001 | ACEI Continuation | Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose. ACEI continuation: These chronic medications will be given without interruption preoperatively. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ACEI Omission | Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose. ACEI 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Interoperative Hypotension | Number of Participants with Interoperative Hypotension (systolic blood pressure under 80 mmHg) | Posted | Count of Participants | Participants | During anesthesia, an expected average of 3 hours. |
|
Hospitalization, expected duration 4 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ACEI Omission | Patients randomized to this arm will be told to hold their final preoperative angiotensin converting enzyme inhibitor dose. ACEI 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MACE | Cardiac disorders | Non-systematic Assessment | Major Adverse Cardiac Event. A composite of acute coronary syndrome, acute heart failure, or new-onset arrhythmia |
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Management decisions were made by the treatment which was not blinded to allocation; Intraoperative hypotension is an intermediate measure but one that has known associations with adverse outcomes, including mortality.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jason Shiffermiller | University of Nebraska Medical Center | 402-559-7299 | jshiffermiller@unmc.edu |
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| ID | Term |
|---|---|
| D000077583 | Quinapril |
| D020913 | Perindopril |
| D017257 | Ramipril |
| C044946 | benazepril |
| D002216 | Captopril |
| D004656 | Enalapril |
| D015773 | Enalaprilat |
| D017328 | Fosinopril |
| D017706 | Lisinopril |
| C052035 | trandolapril |
| C058302 | moexipril |
| ID | Term |
|---|---|
| D044005 | Tetrahydroisoquinolines |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| ACEI omission | Drug | 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. |
|
|
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.
| During anesthesia, an expected average of 3 hours. |
| Older Age Subgroup | 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 | During anesthesia, an expected average of 3 hours. |
| Postoperative Hypertension | Any systolic blood pressure greater than 180 mmHg. | Arrival in PACU to hospital discharge, an expected average of 4 days. |
| Postoperative Hypotension | Any systolic blood pressure less than 90 mmHg | Arrival in PACU to hospital discharge, an expected average of 4 days. |
| 15728043 | Background | 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. |
| 10690132 | Background | 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. |
| 28722845 | Background | 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/ |
| Background | Rate of all-listed procedures for discharges from short-stay hospitals, by procedure category and age: United States, 2010. 2010. |
| 22253266 | Background | 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. |
| 25929547 | Background | 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. |
| 23835589 | Background | 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. |
| 11133595 | Background | 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. |
| 27775997 | Background | 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. Anesthesiology. 2017 Jan;126(1):16-27. doi: 10.1097/ALN.0000000000001404. |
| 25091544 | Background | Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN; American College of Cardiology; American Heart Association. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. J Am Coll Cardiol. 2014 Dec 9;64(22):e77-137. doi: 10.1016/j.jacc.2014.07.944. Epub 2014 Aug 1. No abstract available. |
| 25086026 | Background | Kristensen SD, Knuuti J, Saraste A, Anker S, Botker HE, Hert SD, Ford I, Gonzalez-Juanatey JR, Gorenek B, Heyndrickx GR, Hoeft A, Huber K, Iung B, Kjeldsen KP, Longrois D, Luscher TF, Pierard L, Pocock S, Price S, Roffi M, Sirnes PA, Sousa-Uva M, Voudris V, Funck-Brentano C; Authors/Task Force Members. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management: The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). Eur Heart J. 2014 Sep 14;35(35):2383-431. doi: 10.1093/eurheartj/ehu282. Epub 2014 Aug 1. No abstract available. |
| 17331245 | Background | Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. doi: 10.1186/cc5713. |
| 26083768 | Background | Monk TG, Bronsert MR, Henderson WG, Mangione MP, Sum-Ping ST, Bentt DR, Nguyen JD, Richman JS, Meguid RA, Hammermeister KE. Association between Intraoperative Hypotension and Hypertension and 30-day Postoperative Mortality in Noncardiac Surgery. Anesthesiology. 2015 Aug;123(2):307-19. doi: 10.1097/ALN.0000000000000756. |
| 18375317 | Background | Kheterpal S, Khodaparast O, Shanks A, O'Reilly M, Tremper KK. Chronic angiotensin-converting enzyme inhibitor or angiotensin receptor blocker therapy combined with diuretic therapy is associated with increased episodes of hypotension in noncardiac surgery. J Cardiothorac Vasc Anesth. 2008 Apr;22(2):180-6. doi: 10.1053/j.jvca.2007.12.020. |
| 24681657 | Background | Twersky RS, Goel V, Narayan P, Weedon J. The risk of hypertension after preoperative discontinuation of angiotensin-converting enzyme inhibitors or angiotensin receptor antagonists in ambulatory and same-day admission patients. Anesth Analg. 2014 May;118(5):938-44. doi: 10.1213/ANE.0000000000000076. |
| 23994095 | Background | Tan TW, Eslami MH, Kalish JA, Eberhardt RT, Doros G, Goodney PP, Cronenwett JL, Farber A; Vascular Study Group of New England. The need for treatment of hemodynamic instability following carotid endarterectomy is associated with increased perioperative and 1-year morbidity and mortality. J Vasc Surg. 2014 Jan;59(1):16-24.e1-2. doi: 10.1016/j.jvs.2013.07.025. Epub 2013 Aug 30. |
| 26200181 | Background | Lee SM, Takemoto S, Wallace AW. Association between Withholding Angiotensin Receptor Blockers in the Early Postoperative Period and 30-day Mortality: A Cohort Study of the Veterans Affairs Healthcare System. Anesthesiology. 2015 Aug;123(2):288-306. doi: 10.1097/ALN.0000000000000739. |
| 22715473 | Background | Drenger B, Fontes ML, Miao Y, Mathew JP, Gozal Y, Aronson S, Dietzel C, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. Patterns of use of perioperative angiotensin-converting enzyme inhibitors in coronary artery bypass graft surgery with cardiopulmonary bypass: effects on in-hospital morbidity and mortality. Circulation. 2012 Jul 17;126(3):261-9. doi: 10.1161/CIRCULATIONAHA.111.059527. Epub 2012 Jun 19. |
| 30261084 | Derived | Shiffermiller JF, Monson BJ, Vokoun CW, Beachy MW, Smith MP, Sullivan JN, Vasey AJ, Guda P, Lyden ER, Ellis SJ, Pang H, Thompson RE. 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. |
| BG001 |
| ACEI Continuation |
Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose. ACEI continuation: These chronic medications will be given without interruption preoperatively. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| smoking status | Count of Participants | Participants |
|
| American Society of Anesthesiologists classification | 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 | Mean | Full Range | units on a scale |
|
| preoperative NSAID use | Count of Participants | Participants |
|
| preoperative systolic BP | Mean | Full Range | mmHg |
|
| hypertension history | Count of Participants | Participants |
|
| congestive heart failure history | Count of Participants | Participants |
|
| Additional antihypertensive | Use of at least one additional antihypertensive medication in addition to an angiotensin converting enzyme inhibitor at the time of enrollment. | Count of Participants | Participants |
|
|
|
|
| Secondary | Acute Renal Failure | Creatinine increase of more than 0.3 mg/dl or more than 50% from preoperative level | Missing outcome data for 37 patients, 18 in the ACEI omission arm and 19 in the ACEI continuation arm | Posted | Count of Participants | Participants | Arrival in post-anesthesia care unit (PACU) to hospital discharge, an expected average of 4 days. |
|
|
|
|
| Secondary | Low Blood Pressure Subgroup | 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. | Posted | Count of Participants | Participants | During anesthesia, an expected average of 3 hours. |
|
|
|
|
| Secondary | Older Age Subgroup | 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 | Posted | Count of Participants | Participants | During anesthesia, an expected average of 3 hours. |
|
|
|
|
| Secondary | Postoperative Hypertension | Any systolic blood pressure greater than 180 mmHg. | Posted | Count of Participants | Participants | Arrival in PACU to hospital discharge, an expected average of 4 days. |
|
|
|
|
| Secondary | Postoperative Hypotension | Any systolic blood pressure less than 90 mmHg | Posted | Count of Participants | Participants | Arrival in PACU to hospital discharge, an expected average of 4 days. |
|
|
|
|
| 0 |
| 137 |
| 4 |
| 137 |
| 0 |
| 137 |
| EG001 | ACEI Continuation | Patients in this arm will be randomized to take their final preoperative angiotensin converting enzyme inhibitor dose. ACEI continuation: These chronic medications will be given without interruption preoperatively. | 0 | 138 | 1 | 138 | 0 | 138 |
|
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| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D011392 | Proline |
| D007098 | Imino Acids |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D010721 | Phosphinic Acids |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |