The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Public ClinicalTrials.gov record NCT00060840. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to assess the utility of nitric oxide for inhalation during left ventricular assist device (LVAD) implantation following cardiopulmonary bypass (CPB). This is to be assessed by the number of patients in each treatment group meeting failure criteria within 24 hours on study drug, as defined by two or more of the following: * Left ventricular flow rate index (LVFRI) ≤ 2.0 L/min/m\^2 * Administration of ≥ 20 inotropic equivalents (IE) * 10 µg/kg/min dopamine, dobutamine, enoximone or amrinone is equivalent to 10 IE * 0.1 µg/kg/min epinephrine or norepinephrine is equivalent to 10 IE * 1 µg/kg/min milrinone is equivalent to 15 IE * 0.1 U/min vasopressin is equivalent to 10 IE * Mean arterial pressure (MAP) ≤ 55 mmHg * Central venous pressure (CVP) ≥ 16 mmHg * Percent mixed venous oxygen saturation (SvO2) ≤ 55% Or at least one of the following criteria: * Failure to wean from cardiopulmonary bypass at least once due to hemodynamic failure. Re-initiation of cardiopulmonary bypass to correct bleeding or other technical issues will not be considere 'failure to wean' * Death
Study identification
- NCT ID
- NCT00060840
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 150 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 30, 2003
- Primary completion
- May 31, 2008
- Completion
- Jun 30, 2008
- Last update posted
- Aug 21, 2016
2003 – 2008
United States locations
- U.S. sites
- 8
- U.S. states
- 5
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Newark Beth Isreal Medical Center | Newark | New Jersey | 07112 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Baylor University Medical Center | Dallas | Texas | 75226 | — |
| University of Texas/St. Paul Medical Center | Dallas | Texas | 75390 | — |
| Texas Heart Institute | Houston | Texas | 20345 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00060840, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 21, 2016 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00060840 live on ClinicalTrials.gov.