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| Sponsored by: |
INO Therapeutics |
| Information provided by: | INO Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00060840 |
Purpose
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:
Administration of ≥ 20 inotropic equivalents (IE)
Or at least one of the following criteria:
| Condition | Intervention | Phase |
|
Congestive Heart Failure |
Drug: Nitric Oxide Drug: placebo |
Phase II |
| MedlinePlus related topics: | Heart Failure |
| Drug Information available for: | Nitric oxide |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation |
| Enrollment: | 150 |
| Study Start Date: | July 2003 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
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A: Active Comparator
Stratified based on the LVAD they receive (axial or pulsatile)
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Drug: Nitric Oxide
40ppm of drug will be continuously administered at least 5 minutes prior to initiating the first weaning attempt from CPB
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P: Placebo Comparator
Stratified based on the LVAD they receive (axial or pulsatile)
|
Drug: placebo
Open label investigational drug may be administered once a patient meets a minimum of two failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.
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40 ppm of either nitric oxide for inhalation or N2 (placebo)will be continuously administered to the patient starting at least 5 minutes prior to initiating the first weaning attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study drug for 48 hours following discontinuation of CPB, whichever come first.
All patients will be monitored peri-operatively with a pulmonary arterial line, central venous line, and systemic arterial line. Baseline data collection by a designated clinical staff member will begin following induction of anesthesia and prior to skin incision. Following a successful wean from cardiopulmonary bypass, post-op data will be collected within 1 hour following end time of surgery. Data will then be collected at 6, 12, 18, 24, and 48 hours from post-op or until extubation, in which case weaning from study drug will begin.
Open label investigational nitric oxide for inhalation may be administered once a patient meets a minimum of two of the failure criteria or fails to wean at least once due to hemodynamic failure from cardiopulmonary bypass.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
Contacts and Locations| United States, New Jersey | |||||
| Newark Beth Isreal Medical Center | |||||
| Newark, New Jersey, United States, 07112 | |||||
| United States, North Carolina | |||||
| Duke University Medical Center | |||||
| Durham, North Carolina, United States, 27710 | |||||
| United States, Ohio | |||||
| Cleveland Clinic Foundation | |||||
| Cleveland, Ohio, United States, 44195 | |||||
| University of Cincinnati | |||||
| Cincinnati, Ohio, United States, 45219 | |||||
| United States, Pennsylvania | |||||
| Allegheny General Hospital | |||||
| Pittsburgh, Pennsylvania, United States, 15212 | |||||
| United States, Texas | |||||
| Baylor University Medical Center | |||||
| Dallas, Texas, United States, 75226 | |||||
| University of Texas/St. Paul Medical Center | |||||
| Dallas, Texas, United States, 75390 | |||||
| Texas Heart Institute | |||||
| Houston, Texas, United States, 20345 | |||||
| Germany, Bad Oeynhausen | |||||
| Herz-und Diabeteszentrum Nordrhein-Westfalen | |||||
| Gergstrab, Bad Oeynhausen, Germany, 32545 | |||||
| Germany, Berlin | |||||
| Deutsches Herfzzentrum Berlin | |||||
| Augustenburger Platz, Berlin, Germany, 13353 | |||||
| United Kingdom, Middlesex | |||||
| Harefield Hospital | |||||
| Harefield, Middlesex, United Kingdom, UB96JH | |||||
| INO Therapeutics |
| Study Director: | James Baldassarre, MD | INO Therapeutics |
More Information
| Responsible Party: | INO Therapeutics ( Rob Small ) |
| Study ID Numbers: | INOT 41 |
| First Received: | May 14, 2003 |
| Last Updated: | September 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00060840 |
| Health Authority: | United States: Food and Drug Administration |
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