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

NCT07541222 | Recruiting

• 1 other identifier: 2026/026
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypotension on Induction; Cardiac Surgery; Antihypertensive Agents; Anesthesia, Intravenous; Hemodynamics

Keywords

Post-induction hypotension; Cardiac surgery; Antihypertensive drugs; Hypotension burden; Mean arterial pressure; Anesthesia induction

Outcome Measures

Primary Outcomes (1)

• Post-induction Hypotension (PIH) Burden

  The hypotension burden is defined as the area under the threshold (AUT) for a mean arterial pressure (MAP) \<55 mmHg. It is calculated using the formula: AUT\<55 = ∫(55 - MAP(t))dt for all values where MAP is below 55 mmHg. This measure integrates both the severity and duration of hypotension.

  From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.

Secondary Outcomes (2)

• Total Vasopressor Dose

  From the start of anesthesia induction until 15 minutes post-induction.

• Incidence of Post-induction Hypotension

  From the start of anesthesia induction until 15 minutes post-induction.

Study Arms (1)

Study Cohort

Adult patients aged 18 to 85 years with ASA physical status III-IV, who are scheduled to undergo elective cardiac surgery under general anesthesia.

Other: Chronic Antihypertensive Medication Use

Interventions

Chronic Antihypertensive Medication Use OTHER

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).

Also known as: Multiple Antihypertensive Therapy

Study Cohort

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (40 years and older) who are scheduled for elective cardiac surgery under general anesthesia at a single tertiary center and have been on a stable regimen of one or more antihypertensive medications for at least one month preoperatively.

You may qualify if:

• 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

You may not qualify if:

• 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%

Sponsors & Collaborators

• Konya City Hospital: lead

Study Sites (1)

University of Health Sciences, Konya City Hospital

Konya, 42080, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• 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 BACKGROUND

• 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 BACKGROUND

• 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/AMA/ASPC/NMA/PCNA/SGIM Guideline for the Prevention, Detection, Evaluation and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2025 Sep 16;152(11):e114-e218. doi: 10.1161/CIR.0000000000001356. Epub 2025 Aug 14.

  PMID: 40811497 BACKGROUND

• 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 BACKGROUND

• 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. doi: 10.1093/eurheartj/ehab395. No abstract available.

  PMID: 34453165 BACKGROUND

• 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 Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2018 May 15;71(19):e127-e248. doi: 10.1016/j.jacc.2017.11.006. Epub 2017 Nov 13. No abstract available.

  PMID: 29146535 BACKGROUND

Study Officials

• Mustafa Aydemir, MD

  Konya City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Aydemir, MD

CONTACT

+905378725583; drmustafaaydemir02@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: April 21, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)