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

NCT ID: NCT00981591

Last Updated: 2015-01-19

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2013-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Inhaled Iloprost

Group Type: EXPERIMENTAL

Iloprost

Intervention Type: DRUG

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes

Inhaled Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

Interventions

Iloprost

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes

Intervention Type: DRUG

Placebo

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

Intervention Type: DRUG

Other Intervention Names

Ventavis

Eligibility Criteria

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

• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Actelion

INDUSTRY

Sponsor Role: collaborator

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Delphine Yung

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Delphine Yung, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital

Other Identifiers

SCIL-001-12806

Identifier Type: -

Identifier Source: org_study_id