The Impact of Multiple Antihypertensive Therapy on Post-Induction Hypotension Burden in Cardiac Surgery Patients: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Post-induction Hypotension (PIH) Burden
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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%
研究组 & 干预措施
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.
干预措施: Chronic Antihypertensive Medication Use (Other)
结局指标
主要结局
Post-induction Hypotension (PIH) Burden
时间窗: 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.
次要结局
- Total Vasopressor Dose(From the start of anesthesia induction until 15 minutes post-induction.)
- Incidence of Post-induction Hypotension(From the start of anesthesia induction until 15 minutes post-induction.)
研究者
Mustafa Aydemir
Principal Investigator
Konya City Hospital