Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Terminated
Mallinckrodt
Phase 1/Phase 2
2002-05-01
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas
by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen),
within one hour of initiation and with no significant adverse effects.
Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Terminated
Mallinckrodt
Phase 2
2002-04-01
The purpose of this program is to evaluate the logistic issues and patient requirements for
chronic pulsed INOmax delivery in ambulatory, home-care patients. To understand patient
needs, patients with a variety of underlying diseases will be included. Safety of chronic
therapy will be monitored by serial measurements of methemoglobin, platelet function assay
and reported adverse events.
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
Completed
Mallinckrodt
Phase 2
2003-07-01
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
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