Low Dose Vasopressin vs Phenylephrine in Cardiac Surgery
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Number of patients with acute kidney injury
研究概览
简要总结
This is a randomized, open label study to investigate vasopressin versus phenylephrine as a first line pressor in cardiac surgery. All patients >18 years of age presenting for coronary artery bypass graft (CABG), valve surgery, or combined CABG and valve surgery will be screened for inclusion. Patients with ejection fraction < 35%, > moderate pulmonary hypertension, > mild right ventricular dysfunction, a planned radial arterial graft, or circulatory arrest will be excluded. Patients will be randomized to receive either vasopressin or phenylephrine as the first line vasopressor during the perioperative period to maintain mean arterial blood pressure >65 mmhg. Primary outcome is acute kidney injury. Secondary outcomes are 30-day mortality, stroke, myocardial infarction, re-operation, sternal infection, atrial fibrillation, intensive care unit length of stay, and total vasopressor hours.
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
- None
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
- •>18 years of age
- •Coronary artery bypass graft (CABG), valve, or combined CABG and valve surgery
排除标准
- •Ejection fraction < 35%
- •> moderate pulmonary hypertension
- •> mild right ventricular dysfunction
- •Radial arterial graft
- •Circulatory arrest
研究组 & 干预措施
Vasopressin
Low dose vasopressin as first line vasopressor in cardiac surgery.
干预措施: Vasopressin (Drug)
Phenylephrine
Low dose phenylephrine as first line vasopressor in cardiac surgery
干预措施: Phenylephrine (Drug)
结局指标
主要结局
Number of patients with acute kidney injury
时间窗: 5 Days
KDIGO criteria
次要结局
- Number of patients with 30-Day Mortality(30 Days)
- Number of patients with reoperation(5 Days)
- Number of patients with sternal Infection(5 Days)
- Number of patients with Atrial Fibrilation(5 Days)
- ICU Length of Stay(5 Days)
- Total Vasopressor Hours(5 Days)
研究者
Jordan Goldhammer
Associate Professor of Anesthesiology
Thomas Jefferson University
