Natrecor® (Nesiritide) as a Nitric Oxide Sparing Agent in Patients Undergoing Lung Transplantation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension
研究概览
简要总结
This study seeks to demonstrate that Natrecor® (nesiritide) is safe and effective and has a favorable hemodynamic profile in lung transplant recipients that will allow for the avoidance of inhaled nitric oxide (iNO) use. It is estimated that the use of nesiritide will decrease the otherwise historically mandated use of iNO by 50%, as compared to the necessity of iNO use by matched historical controls.
详细描述
A condition called ischemic reperfusion injury (IRI) occurs in all lung transplants. The amount of reperfusion injury varies from person to person. IRI occurs when the blood supply to tissue (in this case, transplanted lung(s)) is decreased and then is restored. IRI can cause a decrease in function in a newly transplanted lung. When this occurs, or when people have pulmonary hypertension (high blood pressure in your lungs), doctors use Nitric Oxide to improve the pressure and blood supply to the transplanted lung. Nitric Oxide (NO) is given by inhalation while patients are on a ventilator (breathing machine). Because NO must be given by a ventilator and because patients on ventilators must be in an intensive care unit, the cost of treating people with NO is very high. NO can also cause rebound pulmonary hypertension (high blood pressure in the lungs that reoccurs) when it is stopped. Because of these reasons, doctors are looking for other treatments for IRI and pulmonary hypertension. A drug called Natrecor has been shown to reduce pulmonary pressures in heart transplant patients. Doctors believe it may be helpful to lung transplant patients as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Single or double lung transplant or heart/lung transplant recipient
- •Planned use of Natrecor
- •Pulmonary artery (PA) systolic pressures > 35
排除标准
- •Previous lung transplant
- •Use of Prolastin after pneumonectomy
- •Mean arterial pressure of < 55
- •Known allergy or sensitivity to nesiritide
- •Females of childbearing potential with a positive pregnancy test or women who are breast feeding
- •Use of nesiritide, for any reason, within 30 days prior to transplant
研究组 & 干预措施
Natrecor infusion
Nesiritide
干预措施: Natrecor (Drug)
结局指标
主要结局
To evaluate the safety and efficacy of Natrecor® in reducing nitric oxide used perioperatively in patients undergoing single or double lung transplantation who have or are at risk for developing pulmonary hypertension
次要结局
- To compare length of stay in the Intensive Care Unit (ICU)
- To compare pulmonary parameters
- To compare hemodynamic parameters
- To compare total cost-effective evaluation between patients receiving Natrecor and those who received iNO
- To compare duration of mechanical ventilation
- To compare IRI via chest x-ray and PAO2/FIO2 ratio
- To compare renal function as defined by peak serum creatinine and calculated creatinine clearance during the first 72 hours post-transplant
- To compare time to dry weight
- To compare necessity of CPB between Natrecor® versus nitric oxide
- To compare length of stay (total)