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

NCT00981591 | Withdrawn Phase 1 DMC

• 1 other identifier: SCIL-001-12806
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Hypertension; Neonatal Hypoxic Respiratory Failure; Persistent Pulmonary Hypertension of Newborn; Congenital Heart Defects; Acute Respiratory Distress Syndrome

Keywords

Iloprost; Nitric oxide; Mechanical ventilator

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

Study Arms (2)

Inhaled Iloprost

EXPERIMENTAL

Drug: Iloprost

Inhaled Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Iloprost DRUG

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

Also known as: Ventavis

Inhaled Iloprost

Placebo DRUG

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

Inhaled Placebo

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Actelion: collaborator

MeSH Terms

Conditions

Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Heart Defects, Congenital; Respiratory Distress Syndrome

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Congenital Abnormalities; Respiration Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Delphine Yung, MD

  Seattle Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator

Study Record Dates

• First Submitted: September 18, 2009
• First Posted: September 22, 2009
• Study Start: September 1, 2009
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 19, 2015

Record last verified: 2015-01