Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Recruitment status was Recruiting
Research study evaluating the individual and combined effects of inhaled medications, nitric oxide and prostacyclin, 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, the inhaled medication, nitric oxide, is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.
|Study Design:||Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement|
- Pulmonary Hypertension [ Time Frame: Eight Hours after cardiac surgery ] [ Designated as safety issue: No ]Pulmonary hypertension is common during and after cardiac surgery for heart transplant and for LVAD placement. Pulmonary hypertension is a risk factor for right heart dysfunction after these types of surgeries while the patient is in the intensive care unit.
- Right heart dysfunction [ Time Frame: Eight Hours after cardiac surgery ] [ Designated as safety issue: No ]Right heart dysfunction is common after cardiac surgery for heart transplant and for LVAD placement.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2013|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Combined nitric oxide and prostacyclin
combined inhaled nitric oxide 20 ppm continuously and inhaled prostacyclin 0.05 micrograms/kg/min continuously for 2 hours duration
Drug: Nitric Oxide
inhaled nitric oxide
Other Name: INOmaxDrug: Prostacyclin
The study will begin once the participant arrives in the 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'sarterial 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 data will be collected. iPGI2 will then be combined with the current iNO.
- After two hours of combined iNO and iPGI2, data will be collected. iNO will then be stopped.
- Data will be collected after two hours of solo iPGI2 therapy. iNO will be restarted.
- After two hours of combined iNO and iPGI2, data will be collected. The study ends after this data collection time.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717209
|Contact: Andrew J Powers, MDfirstname.lastname@example.org|
|Contact: Charles Hill, MD||(650) email@example.com|
|United States, California|
|Stanford Hospital and Clinics||Recruiting|
|Stanford, California, United States, 94305|
|Contact: Andrew J Powers, MD 734-751-5949|
|Principal Investigator: Andrew J Powers, MD|
|Principal Investigator:||Andrew J Powers, MD|