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

This study has been withdrawn prior to enrollment.
(No patients recruited)
Sponsor:
Collaborator:
Actelion
Information provided by (Responsible Party):
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT00981591
First received: September 18, 2009
Last updated: March 7, 2013
Last verified: March 2013

September 18, 2009
March 7, 2013
September 2009
March 2013   (final data collection date for primary outcome measure)
To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension. [ Time Frame: For the duration of time that the subject is receiving the study drug ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00981591 on ClinicalTrials.gov Archive Site
  • Time to wean off iNO. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Time to extubation. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Total cost of iNO. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean. [ Time Frame: When the participant is successfully weaned off study drug ] [ Designated as safety issue: No ]
  • Time to ICU discharge [ Time Frame: When the participant is successfully weaned off study drug. ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
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

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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Pulmonary Hypertension
  • Neonatal Hypoxic Respiratory Failure
  • Persistent Pulmonary Hypertension of Newborn
  • Congenital Heart Defects
  • Acute Respiratory Distress Syndrome
  • 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 Name: Ventavis
  • Drug: Placebo
    Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
  • Experimental: Inhaled Iloprost
    Intervention: Drug: Iloprost
  • Placebo Comparator: Inhaled Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
March 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00981591
SCIL-001-12806
Yes
Seattle Children's Hospital
Seattle Children's Hospital
Actelion
Principal Investigator: Delphine Yung, MD Seattle Children's Hospital
Seattle Children's Hospital
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP