The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation

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

Timeline

Start

2003-07

Primary completion

2008-06

Completion

2008-07

Drugs

Indications