Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients

Seattle Children's Healthcare System

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

Congenital Heart Defects

Acute Respiratory Distress Syndrome

Persistent Pulmonary Hypertension of Newborn

Pulmonary Hypertension

Neonatal Hypoxic Respiratory Failure

Treatments

Drug: Placebo

Drug: Iloprost

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00981591

SCIL-001-12806

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

Under 21 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Birth to 21 years of age
Diagnosis of pulmonary hypertension must fit into one of three categories
- neonatal hypoxic respiratory failure
- congenital heart disease
- acquired/acute respiratory distress syndrome (lung disease)
Parents of subject must be able and willing to give written informed consent and comply with the requirements of the study protocol and must authorize release and use of protected health information
Patients who remain on nitric oxide at 12 to 18 hours after initiation
Patients who are transferred to an intensive care unit already on inhaled nitric oxide from another institution will be treated as if nitric oxide therapy was started at the time of admission to the unit
Patients will be enrolled only after a clinical decision to treat with nitric oxide has been made by the treating physician

Exclusion criteria

Corrected gestational age less than 35 weeks
Patients with potentially fatal non-cardiopulmonary co-morbidities (e.g. hepatic, neurologic, renal)
Known or suspected fatal genetic syndrome
Patient with cardiac failure secondary to significant left-sided obstructive lesions
Patient on ECMO
Patient on any other form of prostacyclin
Patient on any medication with known NO production, e.g., nitroprusside
Patient on an endothelin receptor antagonist (e.g. bosentan)
Patient on sildenafil
Patient on whom clinicians do not agree to follow standard inhaled nitric oxide weaning protocol
Patients who have known hypersensitivity to prostacyclin or any of its components
Patient who is pregnant
Patient with platelet count less than 50,000