The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 150
- 试验地点
- 11
- 主要终点
- The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.
研究概览
简要总结
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following:
-
Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m^2
-
Administration of ≥ 20 inotropic equivalents (IE)
-
10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE
-
0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE
-
1 µg/kg/min milrinone is equivalent to 15 IE
-
0.1 U/min vasopressin is equivalent to 10 IE
-
Mean arterial pressure (MAP) ≤ 55 mmHg
-
Central venous pressure (CVP) ≥ 16 mmHg
-
Percent mixed venous oxygen saturation (SvO2) ≤ 55%
Or at least one of the following criteria:
- Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean'
- Death
详细描述
40 ppm of either nitric oxide for inhalation or N2 (placebo) will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 hours following discontinuation of CPB, whichever come first.
All patients will be monitored peri-operatively with a pulmonary arterial line, central venous line, and systemic arterial line. Baseline data collection by a designated clinical staff member will begin following induction of anesthesia and prior to skin incision. Following a successful wean from cardiopulmonary bypass, post-op data will be collected within 1 hour following end time of surgery. Data will then be collected at 6, 12, 18, 24, and 48 hours from post-op or until extubation, in which case weaning from study drug will begin.
Open label investigational nitric oxide for inhalation may be administered once a patient meets a minimum of two of the failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nitrogen
Nitrogen (N2) administered at 40 ppm.
干预措施: Nitrogen (Drug)
Inhaled Nitric Oxide
Inhaled Nitric Oxide (iNO) at 40 parts per million (ppm)
干预措施: Nitric Oxide (Drug)
结局指标
主要结局
The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide.
时间窗: 28 days
Failure criteria used to measure outcome includes: * Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m\^2 * Administration of ≥ 20 inotropic equivalents (IE) * Mean arterial pressure (MAP) ≤ 55 mm Hg * Central venous pressure (CVP) ≥ 16 mm Hg * Percentage of mixed venous oxygen saturation (SvO2) of ≤ 55% OR failure to wean from cardio pulmonary bypass (CPB) at least once due to hemodynamic failure or death.
次要结局
未报告次要终点