Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Pulmonary Hypertension
研究概览
简要总结
Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either heart transplant or for left ventricular assist device (LVAD) placement. The investigators hope to learn if these two medications, when given together after surgery, improve right heart function by lowering blood vessel pressures in the lungs. The investigators hope to learn if the combined effects of these two medications are better than either medication used alone. Participants were selected as a possible participant in this study because right heart problems are common during and after surgery for heart transplant and for LVAD placement. In addition, iNO is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.
详细描述
The study will begin once the participant arrives in the cardiothoracic intensive care unit (CTICU) after heart surgery for either heart transplant or LVAD placement. As is standard of care after these types of surgeries, the participant will arrive in the CTICU with a breathing tube already in place, receiving iNO, and connected to a breathing machine. The participant will be receiving relaxing medication in an intravenous line provided by the cardiac anesthesiologist and the CTICU physicians. The participant will be unaware of the study period while the participant is sedated. Data will be collected from the monitor screen connected to the participant's arterial and venous lines, and if placed, LVAD monitor. These data are:
Central venous pressure (CVP) Mean arterial pressure (MAP) Mean pulmonary artery pressure (MPAP) Cardiac Index (CI) Systemic vascular resistance (SVR) Pulmonary vascular resistance (PVR) Right ventricular stroke work index (RVSWI) LVAD Flow LVAD Pulsatility Index (PI)
These data will be collected at five different time periods during the first eight hours after surgery.
- Time zero. Data will be collected after surgery upon your arrival to the CTICU while receiving iNO.
- After two hours of iNO treatment data will be collected. iPGI2 will then be combined with the current iNO.
- After two hours of combined iNO and iPGI2 treatment, data will be collected. iNO will then be stopped.
- After two hours of iPGI2 treatment data will be collected. iNO will be restarted.
- After two hours of combined iNO and iPGI2 treatment, data will be collected. The study ends after this data collection time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Adult cardiac surgical patients scheduled to undergo either heart transplantation or LVAD placement
排除标准
- •Patients with prior documented allergic reactions or intolerance to either nitric oxide or prostacyclin will be excluded. Patients not undergoing heart transplantation or LVAD placement will be excluded.
研究组 & 干预措施
Combined nitric oxide and prostacyclin
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
干预措施: Nitric Oxide (Drug)
Combined nitric oxide and prostacyclin
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
干预措施: Prostacyclin (Drug)
结局指标
主要结局
Pulmonary Hypertension
时间窗: 8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd))
Pulmonary hypertension was measured as mean of Mean Pulmonary Artery Pressure for initial 8 hours after admission to the Intensive Care Unit (ICU). MPAP value ≥25 mmHg (resting) indicates pulmonary hypertension state.
次要结局
- Right Heart Dysfunction(8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd)))
- Systemic Vascular Resistance (SVR)(8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd)))
- Central Venous Pressure (CVP)(8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd)))
- Mean Arterial Pressure (MAP)(8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd)))
- Heart Rate(8 hours (upon arrival at ICU, and after 4 successive 2 hour treatments with 1. iNO only, 2. iNO+iPGI2 (1st), 3. iPGI2 only, and 4. iNO+iPGI2 (2nd)))
研究者
Charles Hill
Clinical Associate Professor
Stanford University