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:

  1. Primary pulmonary hypertension (PPH)
  2. Severe pulmonary hypertension due to congenital (anatomic) heart disease
  3. Pulmonary hypertension or severe impairment of gas exchange in infants and children with chronic lung disease
  4. Pulmonary hypertension or severe impairment of gas exchange due to severe chronic lung disease in adults
  5. 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