University of Health Sciences, Konya City Hospital
Konya, 42080, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07541222
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.
Interested in participating?
Request Info40 year and older
All sexes
Observational
Konya, 42080, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Konya City Hospital
Other
The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients: A Prospective Observational Cohort Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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