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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07541222
Enrollment
160
Registered
2026-04-21
Start date
2026-05-01
Completion date
2026-12-01
Last updated
2026-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed description

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.

Interventions

OTHERChronic 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).

Sponsors

Konya City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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%

Design outcomes

Primary

MeasureTime frameDescription
Post-induction Hypotension (PIH) BurdenFrom the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.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.

Secondary

MeasureTime frameDescription
Total Vasopressor DoseFrom the start of anesthesia induction until 15 minutes post-induction.The total amount of vasopressors (e.g., ephedrine, norepinephrine) administered to treat post-induction hypotension.
Incidence of Post-induction HypotensionFrom the start of anesthesia induction until 15 minutes post-induction.Percentage of patients experiencing at least one episode of MAP \<55 mmHg.

Countries

Turkey (Türkiye)

Contacts

CONTACTMustafa Aydemir, MD
drmustafaaydemir02@gmail.com+905378725583
PRINCIPAL_INVESTIGATORMustafa Aydemir, MD

Konya City Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 7, 2026