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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorKonya City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Emergency surgery

Preoperative shock or requirement for high-dose inotropic/vasopressor therapy

End-stage liver or kidney failure

Uncontrolled hypertension

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Chronic Antihypertensive Medication Use

    Other intervention

    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).

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Study Cohort1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Total Vasopressor Dose

The total amount of vasopressors (e.g., ephedrine, norepinephrine) administered to treat post-induction hypotension.

Time frame
From the start of anesthesia induction until 15 minutes post-induction.
2

Incidence of Post-induction Hypotension

Percentage of patients experiencing at least one episode of MAP \<55 mmHg.

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

Other outcomes

Sponsors and contacts

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