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

May 5, 2026 updated by: Mustafa Aydemir, Konya City Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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%

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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).
Other Names:
  • Multiple Antihypertensive Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-induction Hypotension (PIH) Burden
Time Frame: From 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.
From the start of anesthesia induction until 15 minutes post-induction or until central venous catheter placement, whichever occurs first.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Vasopressor Dose
Time Frame: From 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.
From the start of anesthesia induction until 15 minutes post-induction.
Incidence of Post-induction Hypotension
Time Frame: From the start of anesthesia induction until 15 minutes post-induction.
Percentage of patients experiencing at least one episode of MAP <55 mmHg.
From the start of anesthesia induction until 15 minutes post-induction.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konya City Hospital

Investigators

  • Principal Investigator: Mustafa Aydemir, MD, Konya City Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 14, 2026

First Submitted That Met QC Criteria

April 14, 2026

First Posted (Actual)

April 21, 2026

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2026/026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

De-identified individual participant data underlying the results reported in this article will be available after publication to researchers who provide a methodologically sound proposal.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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