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Inhaled Nitric Oxide and Inhaled Prostacyclin After Cardiac Surgery for Heart Transplant or LVAD Placement

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01717209
First Posted: October 30, 2012
Last Update Posted: October 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Charles Hill, Stanford University
  Purpose
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.

Condition Intervention Phase
Heart Failure Drug: Nitric Oxide Drug: Prostacyclin Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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

Resource links provided by NLM:


Further study details as provided by Charles Hill, Stanford University:

Primary Outcome Measures:
  • Pulmonary Hypertension [ Time Frame: 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.


Secondary Outcome Measures:
  • Right Heart Dysfunction [ Time Frame: 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)) ]
    Right Heart Dysfunction was measured as mean of Right Ventricular Stroke Work Index (RVSWI) for the initial 8 hours after admission to the Intensive Care Unit (ICU). RVSWI is measured as the difference in mean pulmonary artery pressure (MPAP) and central venous pressure (CVP), divided by the cardiac index (CI): [(MPAP-CVP) / CI]. Normal range for RVSWI is 5-10 g/m.

  • Systemic Vascular Resistance (SVR) [ Time Frame: 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) was measured as mean of Systemic Vascular Resistance (SVR) for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for SVR is 800-1200 dynes/sec/cm5.

  • Central Venous Pressure (CVP) [ Time Frame: 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) was measured as mean of CVP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for CVP is 3-8 mmHg.

  • Mean Arterial Pressure (MAP) [ Time Frame: 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) was measured as mean of MAP for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for MAP is 70-110 mmHg.

  • Heart Rate [ Time Frame: 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 was measured as mean of Heart Rate for the initial 8 hours after admission to the Intensive Care Unit (ICU). Normal range for heart rate is generally 60 to 100 beats per minutes in adults, but this can vary.


Enrollment: 14
Actual Study Start Date: October 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Combined nitric oxide and prostacyclin
iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
Drug: Nitric Oxide
inhaled nitric oxide
Other Name: INOmax
Drug: Prostacyclin
inhaled prostacyclin
Other Names:
  • inhaled flolan
  • epoprostenol
  • inhaled PGI2

Detailed Description:

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717209


Locations
United States, California
Stanford Hospital and Clinics
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Andrew J Powers, MD
  More Information

Publications:
Responsible Party: Charles Hill, Clinical Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01717209     History of Changes
Other Study ID Numbers: 25471
First Submitted: October 26, 2012
First Posted: October 30, 2012
Results First Submitted: August 29, 2017
Results First Posted: October 9, 2017
Last Update Posted: October 9, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Charles Hill, Stanford University:
heart failure
hypertension, pulmonary
heart failure, right-sided
heart-assist devices
Heart Transplantation

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Nitric Oxide
Tezosentan
Epoprostenol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Gasotransmitters
Protective Agents
Antihypertensive Agents
Platelet Aggregation Inhibitors