The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients

Официальное название

The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients: A Prospective Observational Cohort Study

Обзор

This study aims to investigate the impact of multiple preoperative antihyperstensive drug use on the burden of post-induction hypotension (PIH) in patients undergoing elective cardiac surgery. The researchers will observe whether the combination of different antihypertensive classes (such as ACE inhibitors, ARBs, beta-blockers, and calcium channel blockers) leads to a higher incidence and severity of blood pressure drops and increased need for vasoactive support during the period between anesthesia induction and surgical incision.

Подробное описание

Post-induction hypotension (PIH) is a critical period in cardiac anesthesia that can lead to organ hypoperfusion. This prospective observational study will include patients aged 18-85 with ASA III-IV physical status scheduled for elective cardiac surgery.

Preoperatively, patients' chronic antihypertensive medications will be recorded and categorized. Following standard anesthesia induction, hemodynamic parameters will be monitored using invasive arterial blood pressure measurement. PIH burden will be defined as the area under the curve (AUC) for a mean arterial pressure (MAP) lower than 65 mmHg. Additionally, the study will record the total dose of ephedrine or other vasoactive agents required to maintain hemodynamic stability. The primary goal is to determine if multiple antihypertensive therapy is an independent risk factor for increased PIH burden and to compare the effects of different drug combinations on early intraoperative hemodynamics.

Вмешательства

• Другое Chronic Antihypertensive Medication Use
  Patients' chronic antihypertensive drug use (number of drugs and pharmacological classes) will be recorded. This is an observational study where existing medication regimens (ACE inhibitors, ARBs, Beta-blockers, Calcium Channel Blockers, Diuretics) are documented to analyze their impact on the post-induction hypotension burden (MAP \< 55 mmHg).

Первичные конечные точки

• Post-induction Hypotension (PIH) Burden [Срок оценки: From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.]

Вторичные конечные точки (2)

• Total Vasopressor Dose [Срок оценки: From the start of anesthesia induction until 15 minutes post-induction.]
• Incidence of Post-induction Hypotension [Срок оценки: From the start of anesthesia induction until 15 minutes post-induction.]

Критерии участия

Критерии включения

• Adult patients aged 40 years and older
• Undergoing elective cardiac surgery (e.g., isolated CABG, isolated valve surgery, or combined CABG+valve surgery via sternotomy)
• Regular use of at least one antihypertensive medication for at least 4 weeks prior to the operation date
• Voluntary participation and signed informed consent

Критерии исключения

• Emergency surgery
• Preoperative shock or requirement for high-dose inotropic/vasopressor therapy
• End-stage liver or kidney failure
• Uncontrolled hypertension
• Difficult intubation or prolonged induction process
• Ejection fraction less than 35%

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 1 центр

• University of Health Sciences, Konya City Hospital — Konya

Публикации

• Chen B, Pang QY, An R, Liu HL. A systematic review of risk factors for postinduction hypotension in surgical patients undergoing general anesthesia. Eur Rev Med Pharmacol Sci. 2021 Nov;25(22):7044-7050. doi: 10.26355/eurrev_202111_27255. PMID 34859868
• Hojo T, Kimura Y, Shibuya M, Fujisawa T. Predictors of hypotension during anesthesia induction in patients with hypertension on medication: a retrospective observational study. BMC Anesthesiol. 2022 Nov 11;22(1):343. doi: 10.1186/s12871-022-01899-9. PMID 36368916
• Writing Committee Members*; Jones DW, Ferdinand KC, Taler SJ, Johnson HM, Shimbo D, Abdalla M, Altieri MM, Bansal N, Bello NA, Bress AP, Carter J, Cohen JB, Collins KJ, Commodore-Mensah Y, Davis LL, Egan B, Khan SS, Lloyd-Jones DM, Melnyk BM, Mistry EA, Ogunniyi MO, Schott SL, Smith SC Jr, Talbot AW, Vongpatanasin W, Watson KE, Whelton PK, Williamson JD. 2025 AHA/ACC/AANP/AAPA/ABC/ACCP/ACPM/AGS/AM PMID 40811497
• Praz F, Lanz J, Adamo M, Borger M. Reply to Garcia-Villarreal et al. concerning the 2025 ESC/EACTS Guidelines for the Management of Valvular Heart Disease. Eur J Cardiothorac Surg. 2025 Nov 2;67(11):ezaf393. doi: 10.1093/ejcts/ezaf393. No abstract available. PMID 41217787
• Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632 PMID 34453165
• Whelton PK, Carey RM, Aronow WS, Casey DE Jr, Collins KJ, Dennison Himmelfarb C, DePalma SM, Gidding S, Jamerson KA, Jones DW, MacLaughlin EJ, Muntner P, Ovbiagele B, Smith SC Jr, Spencer CC, Stafford RS, Taler SJ, Thomas RJ, Williams KA Sr, Williamson JD, Wright JT Jr. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High PMID 29146535

Идентификаторы

NCT: NCT07541222 · 2026/026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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