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

Sponsor

Seattle Children's Hospital (Other)

Overall Status

Withdrawn

CT.gov ID

NCT00981591

Collaborator

Actelion (Industry)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Hypertension Neonatal Hypoxic Respiratory Failure Persistent Pulmonary Hypertension of Newborn Congenital Heart Defects Acute Respiratory Distress Syndrome	Drug: Iloprost Drug: Placebo	Phase 1/Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Mar 1, 2013

Actual Study Completion Date :

Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Inhaled Iloprost	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 Other Names: Ventavis
Placebo Comparator: Inhaled Placebo	Drug: Placebo Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

Arm

Intervention/Treatment

Experimental: Inhaled Iloprost

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

Other Names:

Ventavis

Placebo Comparator: Inhaled Placebo

Drug: Placebo

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

Outcome Measures

Primary Outcome Measures

To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension. [For the duration of time that the subject is receiving the study drug]

Secondary Outcome Measures

Time to wean off iNO. [When the participant is successfully weaned off study drug]
Time to extubation. [When the participant is successfully weaned off study drug]
Total cost of iNO. [When the participant is successfully weaned off study drug]
Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean. [When the participant is successfully weaned off study drug]
Time to ICU discharge [When the participant is successfully weaned off study drug.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts 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