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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

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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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Konya City Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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