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NCT00060840 · ClinicalTrials.gov registry record · Phase 2
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
A Phase 2 study, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
NCT00060840 is a Phase 2 study that has completed, run by Mallinckrodt. The registered enrollment target is 150 participants.
The verdict
NCT00060840, a Phase 2 study, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
Study 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
Interventions
- DRUG Nitric Oxide
- DRUG Nitrogen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2003-07 |
| Est. Completion | 2008-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00060840
The ClinicalTrials.gov registry entry for NCT00060840 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mallinckrodt, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nitric Oxide is the first listed.
NCT00060840 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00060840 about?
NCT00060840 is a clinical study titled "The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation". 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 stu...
What is the current status of trial NCT00060840?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2003-07. Estimated completion is 2008-07.
What interventions are being tested in trial NCT00060840?
The interventions under investigation include: Nitric Oxide (DRUG), Nitrogen (DRUG).
Who is sponsoring clinical trial NCT00060840?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
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