Trials / Withdrawn
WithdrawnNCT00981591
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
A Randomized, Double Blind, Placebo-controlled Pilot Study of the Safety and Effective Dosing of Inhaled Iloprost in Pediatric Patients With Pulmonary Hypertension Treated With Inhaled Nitric Oxide
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Seattle Children's Hospital · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
Detailed description
Inhaled nitric oxide (NO) is used in the management of all causes of pediatric pulmonary hypertension. Despite widespread use of nitric oxide to treat critically ill mechanically-ventilated pediatric patients with pulmonary hypertension, response to therapy is not universal. Nitric oxide fails to improve oxygenation in approximately 30% of these patients. Nonresponders to nitric oxide have few treatment options. Iloprost is the only other medication approved for inhalational delivery in the treatment of pulmonary hypertension. Inhalation therapy for pulmonary vasodilatation in critically ill children is inherently more attractive than oral or intravenous therapies due to the ability to deliver medication directly to the lung and to decrease systemic effects. The use of inhaled iloprost has been reported to decrease pulmonary vascular resistance in many pediatric pathologic settings, including combination therapy with nitric oxide.
Conditions
- Pulmonary Hypertension
- Neonatal Hypoxic Respiratory Failure
- Persistent Pulmonary Hypertension of Newborn
- Congenital Heart Defects
- Acute Respiratory Distress Syndrome
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Iloprost | Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes |
| DRUG | Placebo | Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2013-03-01
- Completion
- 2013-03-01
- First posted
- 2009-09-22
- Last updated
- 2015-01-19
Source: ClinicalTrials.gov record NCT00981591. Inclusion in this directory is not an endorsement.