Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/11/2017 |
| Start Date: | October 2012 |
| End Date: | October 2013 |
Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement
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.
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.
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.
1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while
receiving iNO.
2. After two hours of iNO treatment data will be collected. iPGI2 will then be combined
with the current iNO.
3. After two hours of combined iNO and iPGI2 treatment, data will be collected. iNO will
then be stopped.
4. After two hours of iPGI2 treatment data will be collected. iNO will be restarted.
5. After two hours of combined iNO and iPGI2 treatment, data will be collected. The study
ends after this data collection time.
(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.
1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while
receiving iNO.
2. After two hours of iNO treatment data will be collected. iPGI2 will then be combined
with the current iNO.
3. After two hours of combined iNO and iPGI2 treatment, data will be collected. iNO will
then be stopped.
4. After two hours of iPGI2 treatment data will be collected. iNO will be restarted.
5. After two hours of combined iNO and iPGI2 treatment, data will be collected. The study
ends after this data collection time.
Inclusion Criteria:
- Adult cardiac surgical patients scheduled to undergo either heart transplantation or
LVAD placement
Exclusion Criteria:
- 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.
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