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| Brief Title † | The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation | ||||
| Official Title † | The Effects of Nitric Oxide for Inhalation During Left Ventricular Assist Device (LVAD) Implantation | ||||
| Brief 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:
Or at least one of the following criteria:
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| Detailed Description | 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. |
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| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Primary Outcome Measure † | The primary objective of the trial is to assess the utility of nitric oxide for inhalation for the management of acute right ventricular failure during LVAD placement. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ] | ||||
| Secondary Outcome Measure † | |||||
| Condition † | Congestive Heart Failure | ||||
| Intervention † | Drug: Nitric Oxide Drug: placebo |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Completed | ||||
| Enrollment † | 150 | ||||
| Start Date † | July 2003 | ||||
| Completion Date | July 2008 | ||||
| Eligibility Criteria † | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States, Germany, United Kingdom | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00060840 | ||||
| Organization ID | INOT 41 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | INO Therapeutics | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | INO Therapeutics | ||||
| Verification Date | September 2008 | ||||
| First Received Date † | May 14, 2003 | ||||
| Last Updated Date | September 23, 2008 | ||||