Vasopressin Versus Norepinephrine for the Management of Shock After Cardiac Surgery
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Composite endpoint of major morbidity according to Society of Thoracic Surgery
研究概览
简要总结
Vasoplegic syndrome after cardiac surgery is a common complication after cardiac surgery, with negative impact on patient outcomes and hospital costs. Pathogenesis of vasodilatory phenomenon after cardiac surgery remains a matter of controversy. Loss of vascular tone can be partly explained by the depletion of neurohypophyseal arginine vasopressin stores. The investigators hypothesized that the use of arginine vasopressin would be more effective on treatment of shock after cardiac surgery than norepinephrine, decreasing the composite end point of mortality and severe morbidity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •need vasopressor support
排除标准
- •younger than 18 years;
- •surgery without cardiopulmonary bypass;
- •emergency procedure;
- •ascending and descending thoracic aortic procedures;
- •left ventricular aneurysm resection; enrollment in another study;
- •pregnancy;
- •neoplasm;
- •Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- •severe hyponatremia (Na<130mEq/L);
- •acute mesenteric ischemia;
- •acute myocardial infarction;
- •cardiogenic shock; and refusal to consent
研究组 & 干预措施
Norepinephrine group
Blinded norepinephrine
干预措施: Norepinephrine (Drug)
Vasopressin Group
Blinded vasopressin
干预措施: Vasopressin (Drug)
结局指标
主要结局
Composite endpoint of major morbidity according to Society of Thoracic Surgery
时间窗: 30 days
The primary end point is major morbidity according to STS (30-days mortality, mechanical ventilation \> 48 hours, mediastinitis, surgical reexploration, stroke, acute renal failure)
次要结局
- Hemodynamic effects(28 days)
- occurence of adverse events and safety(28 days)
- Time on mechanical ventilation(30 days)
- Incidence of infecction(30-days)
- Length of ICU and Hospital stay(90 days)
研究者
Ludhmila Abrahão Hajjar
principal investigator
University of Sao Paulo