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The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified health advice, travels to or treatment by using a genuine physician. We are not physicians. Always consult your dr. on The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation Clinical research trials and The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation health trials occur in hundreds of cities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new drugs. The propose of the studies / undertakings is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector companies to locate treatments for all sorts of conditions, including The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation. The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation Clinical Trials and other clinical trials permit volunteers to acquire medical treatment choices before they are available to the masses. Some times the test subjects obtain professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation clinical trial. Participants oftentimes recieve the most expert healthcare available for their The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation condition. Hazards are a reality, however, and can include extra or frequent physician visits, health risks (potentially life-endangering), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation  The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
For Condition: Congestive Heart Failure
Status: Recruiting
Sponsor(s): INO Therapeutics ,
Synopsis: The purpose of this study is to assess the effects 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, as defined by two or more of the following: - Left ventricular flow rate index (LVFRI) <= 1.8 L/min/m2 - Administration of >= 1 ug/kg/min epinephrine or norepinephrine - Mean arterial pressure (MAP) <= 50 mmHg - Central venous pressure (CVP) >= 20 mmHg - Mixed venous oxygen saturation (SvO2) <= 55%
Details: Patients will receive 40 ppm of either nitric oxide for inhalation or placebo continuously starting at least 5 minutes prior to initiating the first attempt from CPB and continue until the patient is either extubated, has reached failure criteria, or has been treated with study gas for 24 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 and prior to exiting the operating room, data will be again collected upon admission to the ICU. Data will then be collected every 6 hours from the point study gas was started until extubation, or until 24 hours of study gas administration, in which case weaning from study gas will begin. Open label investigational nitric oxide for inhalation may be administered once a patient meets failure criteria or fails to wean two or more times from cardiopulmonary bypass.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Scheduled to undergo their first elective LVAD implantation. Exclusion criteria: - Had elective biventricular assist device (BiVAD) surgery. - Pregnant. - Received nitric oxide therapy or other investigational drug within the past 24 hours.
Total Enrollment: 100
Location and Contact Information:
Newark Beth Isreal Medical Center *Not yet recruiting*
Newark, New Jersey, 07112
United States
Not yet recruiting Mark Zucker
St. Paul University Hospital *Recruiting*
Dallas, Texas, 75235
United States
Recruiting Dan Meyer
Duke University Medical Center *Not yet recruiting*
Durham, North Carolina, 27710
United States
Not yet recruiting Carmelo Milano
Cleveland Clinic Foundation *Not yet recruiting*
Cleveland, Ohio, 44195
United States
Not yet recruiting Jean-Pierre Yared
Baylor University Medical Center *Recruiting*
Dallas, Texas, 75226
United States
Recruiting Michael Ramsay
Additional Information:
Study ID Numbers: INOT 41;
Study Start Date: June 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00060840
Other Congestive Heart Failure Studies:
1. MYOHEARTâ„¢ (Myogenesis Heart Efficiency and Regeneration Trial)
2. Oxypurinol compared with Placebo for Class III-IV NYHA Congestive Heart Failure
3. Safety and efficacy study of the vasopressin receptor antagonist conivaptan in patients with acute decompensated heart failure
4. DITPA, A Thyroid Hormone Analog to Treat Heart Failure
5. Multicenter, Randomized, Double-Blind, Placebo Controlled, Efficacy Study on the Effects of Tolvaptan on Left Ventricular Dilatation in Congestive Heart Failure Patients
Related Studies:
Other Congestive Heart Failure Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
The Effects of Nitric Oxide for Inhalation During Left Ventricular Assists Device (LVAD) Implantation
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