Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement
Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Failure
Intervention: Nitric Oxide (Drug); Prostacyclin (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Stanford University Official(s) and/or principal investigator(s): Andrew J Powers, MD, Principal Investigator
Overall contact: Andrew J Powers, MD, Phone: 650-723-2300, Email: apowers@stanford.edu
Summary
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.
Clinical Details
Official title: Combined Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplantation and for Left Ventricular Assist Device Placement
Study design: Endpoint Classification: Pharmacodynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Pulmonary Hypertension
Secondary outcome: Right heart dysfunction
Detailed description:
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.
1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while
receiving iNO.
2. After two hours data will be collected. iPGI2 will then be combined with the current
iNO.
3. After two hours of combined iNO and iPGI2, data will be collected. iNO will then be
stopped.
4. Data will be collected after two hours of solo iPGI2 therapy. iNO will be restarted.
5. After two hours of combined iNO and iPGI2, data will be collected. The study ends after
this data collection time.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- adult cardiac surgical patients scheduled to undergo either heart transplantation or
left ventricular assist device (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.
Locations and Contacts
Andrew J Powers, MD, Phone: 650-723-2300, Email: apowers@stanford.edu
Stanford Hospital and Clinics, Stanford, California 94305, United States; Recruiting Andrew J Powers, MD, Phone: 734-751-5949 Andrew J Powers, MD, Principal Investigator
Additional Information
Starting date: October 2012
Last updated: October 29, 2012
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