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

Pulmonary Hypertension Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00981591
• Other study ID #: SCIL-001-12806
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: September 18, 2009
• Last updated: January 15, 2015
• Start date: September 2009
• Est. completion date: March 2013

Study information

• Verified date: January 2015
• Source: Seattle Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Congenital Heart Defects
• Heart Defects, Congenital
• Hypertension
• Hypertension, Pulmonary
• Neonatal Hypoxic Respiratory Failure
• Persistent Fetal Circulation Syndrome
• Persistent Pulmonary Hypertension of Newborn
• Pulmonary Hypertension
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seattle Children's Hospital	Actelion

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Time to wean off iNO.		When the participant is successfully weaned off study drug	No
Secondary	Time to extubation.		When the participant is successfully weaned off study drug	No
Secondary	Total cost of iNO.		When the participant is successfully weaned off study drug	No
Secondary	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	No
Secondary	Time to ICU discharge		When the participant is successfully weaned off study drug.	No