Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,013
- 试验地点
- 74
- 主要终点
- The incidence of newly occurring HR ≥ 100 beats/min
研究概览
简要总结
This is a national, multicentre, prospective, open, two-arm, non-interventional study with hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension, wherein the patients are assigned to a treatment arm based on the department.
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
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inpatients, who received IV treatment (bolus administration) with cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterial hypotension
- •Consent to use of data is available
- •Patient under careful blood pressure and pulse monitoring (at least 2 minutes measuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutes after the first application of cafedrine/theodrenaline or ephedrine)
- •Treatment of hypotension in < 100 mm Hg syst. and/or drop in blood pressure > 20% syst. compared to preoperative base value (syst.)
- •Patients ≥ 50 years old
- •Pre-existing comorbidities (ASA classification 2-4)
- •Elective surgery
- •General anaesthesia with propofol/fentanyl ≥ 0.2 mg (or equivalent)
- •Treatment of hypotension in < 100 mm Hg syst. and/or drop in blood pressure > 10% syst. compared to preoperative base value (syst.)
- •Patients ≥ 18 years old
- •Caesarean section under spinal anaesthesia
排除标准
- •Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information
- •Hypersensitivity to any product ingredient
- •Hypertensive blood pressure readings
- •Mitral stenosis
- •Narrow-angle glaucoma
- •Hyperthyroidism
- •Pheochromocytoma
- •Prostatic adenoma with urinary retention
- •Bronchial asthmatics with sulphite sensitivity
- •Hyper-excitability
- •Arteriosclerosis
- •Treatment with other indirect sympathomimetic drugs (Example: phenylpropanolamine, phenylephrine, pseudoephedrine or methylphenidate)
- •Use of Monoamine oxidase (MAO) inhibitors (including within the last two weeks)
- •Prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives
- •Sepsis, septic shock or systemic inflammatory response syndrome (SIRS)
- •Intra-cranial surgery or heart surgery
- •High-risk pregnancy (emergency Caesarean, severe infantile malformation)
- •Multiple pregnancy
- •Amniotic infection syndrome
研究组 & 干预措施
Cohort A
Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
干预措施: Cafedrine/theodrenaline (Drug)
Cohort A
Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
干预措施: Ephedrine (Drug)
Cohort B
Patients, who undergo caesarean section under spinal anaesthesia
干预措施: Cafedrine/theodrenaline (Drug)
Cohort B
Patients, who undergo caesarean section under spinal anaesthesia
干预措施: Ephedrine (Drug)
结局指标
主要结局
The incidence of newly occurring HR ≥ 100 beats/min
时间窗: during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine
Weighted deviation below the individually determined, lowest systolic blood pressure BPmin
时间窗: within the first 15 minutes after the initial delivery of the antihypotonic drug as area1 (AUC) between the systolic blood pressure curve (below BPmin) and the lower limit BPmin
次要结局
未报告次要终点