Hemodynamic Instability Prevented With Polaramine® Infusion Before Extracorporeal Circulation
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)
研究概览
简要总结
This single-institution randomized controlled trial prospective will enrolled 48 patients scheduled for an aortic valve replacement. The objective of the present investigation is to determine the role of Polaramine® on reducing hemodynamic instability after separation from cardiopulmonary bypass (CPB) during cardiac surgery. Our hypothesis is that Polaramine® play an important role reducing dysfunction of the autonomic nervous system and hemodynamic stability after separation from CPB.
详细描述
Vasoplegic syndrome is recognized as a common complication after CPB. Its incidence ranges from 5% to 25% after cardiac surgery requiring CPB. Such syndrome is related to an inflammatory reaction, which is attributed to the CPB. This syndrome is typically characterized by a combination of different parameters with low specificity and sensitivity, such as low systemic vascular resistance leading to a hypotension imposing perfusion of vasopressors with high or normal cardiac outputs.
Investigators preliminary data suggest that vasoplegic syndrome might be related to heart manipulation during surgery. Tearing maneuvers performed on the heart chambers trigger peaks pressure stimulating, consequently, baroreceptors and finally resulting in arteriovenous vasodilation via neurogenic and endogenous pathways. According to investigators initial investigation, such reaction appears to be related to basophils degranulation and release of vasoactive substances.
The hypothesis of the present trial is that a reduction of basophils degranulation and release of vasoactive substances via an antihistaminic could lower the incidence of the vasoplegic syndrome. This study aims to determine the effect of an antihistamine (dexchlorpheniramine (Polaramine®)) administered intravenously before CPB, on the vasoplegic syndrome incidence after separation from CPB.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men aged 18 and older
- •Post menopausal women
- •Patients scheduled for an aortic valve replacement with a traditional sternotomy and CPB
排除标准
- •Patients with a left ventricular ejection fraction lower than 40%
- •Patients with pulmonary arterial hypertension higher than 50mm of Hg,
- •Redo cardiac surgery,
- •Atrioventricular and intraventricular conduction disturbances
- •Epilepsy or convulsions
- •Atopic disease
- •Women of childbearing potential
- •Patients at risk of glaucoma
- •Patients with therapy interacting with dexchlorpheniramine (Polaramine®).
- •Patients unable to provide a signed informed consent
研究组 & 干预措施
Control group
24 patients
干预措施: Placebo injection (Drug)
Treatment group
24 patients
干预措施: dexchlorpheniramine (Polaramine®) injection (Drug)
结局指标
主要结局
Assesment of patients proportion with abnormal ratio of sympathic-parasympathetic balance (>1.2)
时间窗: Day 2
The calculation of every ratio will be made by a software in the department
次要结局
- Peaks of pressure measure in the lung artery perioperative(Day 0, day 1, day 2)
- Duration of hospital stay(Day 28)
- Mortality(Day 28, month 6)
- Collection of adverse events potentially related to the treatment(Day 0, day1, day 2, day 28, month 6)
- Blood dosage of histamine(Day 0)
- Assesment of patients proportion presenting metabolic disease, with abnormal ratio of sympathic-parasympathetic balance (>1.2)(Day 0, day 1, day 2)
- Measure of the amount of catecholamine infused(Day 0, day 1, day 2)
- Assesment of the postoperative complications incidence(Day 28, month 6)
- Immunophenotypage of basophilic polynuclears(Day 0)
- Measure of the amount of fluids delivered(Day 0, day1, day 2)