Phase 2
Completed N=150
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Source: ClinicalTrials.gov NCT00060840 ↗Enrolled (actual)
150
Serious AEs
12.0%
Results posted
Sep 2010
Primary outcomePrimary: The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide. — 7; 12 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Subjects With Left Ventricular Failure During Left Ventricular Assistance Device (LVAD) Placement After Cardio Pulmonary Bypass, as Determined by Failure Criteria, After Administration of Nitric Oxide. |
7; 12 | — |
Eligibility Criteria
Inclusion criteria
- Scheduled to undergo their first LVAD implantation, (or at least 6 months after explanation of a previous LVAD).
- Has a pulmonary vascular resistance of at least 2.5 Wood units (200 dynes/sec.) in the 30 days prior to LVAD placement.
- Greater than 18 years of age.
- Signed IRB approved informed consent.
Exclusion criteria
- Patients with congestive heart failure due to giant cell myocarditis or restrictive cardiomyopathy.
- Elective Biventricular Assist Device (BiVAD) surgery, or current support with a temporary BiVad.
- LVAD procedure expected to be done without cardiopulmonary bypass.
- Pregnancy (a negative pregnancy test must be documented prior to enrollment).
- Received nitric oxide by inhalation therapy within the past 24 hours.
- Investigational drugs that are expected to change systemic or pulmonary vascular resistance are not allowed.
Data sourced from ClinicalTrials.gov (NCT00060840). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.