Clinical Trial: Hospital-Based Program for Treatment of Severe Cardiopulmonary Disease With Inhaled Nitric Oxide
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Development of a Hospital-Based Home Program for the Use of Inhaled Nitric Oxide in the Chronic Management of Severe Cardiopulmonary Diseases
Brief Summary: 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.
Detailed Summary:
This study will help develop a comprehensive home care program using INOmax delivery systems. This study will enroll a limited number of patients (5-7) from several disease categories in order to develop the experience with testing acute and chronic responsiveness to INO therapy. The following groups will be tested:
- Primary pulmonary hypertension (PPH)
- Severe pulmonary hypertension due to congenital (anatomic) heart disease
- Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
- Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
- Pulmonary hypertension or severe impairment of gas exchange in hematologic and transplant disorders - young children and adults with sickle cell disease, chronic lung disease after bone marrow transplant, cardiac transplant, or lung transplant
Sponsor: Mallinckrodt
Current Primary Outcome: Methemoglobin level [ Time Frame: 24 and 72 hours after treatment start, then at 1, 3, 6, 9 and 12 months ]
Original Primary Outcome:
Current Secondary Outcome:
- Vital Signs [ Time Frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment begins, then at 1, 3, 6, 9 and 12 months ]
- Pulse Oximetry [ Time Frame: taken at 1, 2, 3, 4, 24, and 72 hours after treatment start and then at 1, 3, 6, 9 and 12 months ]
- Adverse Event Occurence [ Time Frame: Study Duration ]
- Echocardiogram [ Time Frame: At 72 hours after treatment start, then at 3, 6, 9 and 12 months ]
Original Secondary Outcome:
Information By: Mallinckrodt
Dates:
Date Received: July 10, 2002
Date Started: April 2002
Date Completion:
Last Updated: September 8, 2016
Last Verified: September 2016