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

Primary Purpose

Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Iloprost
Placebo
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Iloprost, Nitric oxide, Mechanical ventilator

Eligibility Criteria

undefined - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Inhaled Iloprost

    Inhaled Placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    To determine the safety and effective dosing of inhaled iloprost in mechanically ventilated pediatric patients with pulmonary hypertension.

    Secondary Outcome Measures

    Time to wean off iNO.
    Time to extubation.
    Total cost of iNO.
    Incidence of rebound phenomenon, as defined by the need to return to a higher iNO dose after a previous wean.
    Time to ICU discharge

    Full Information

    First Posted
    September 18, 2009
    Last Updated
    January 15, 2015
    Sponsor
    Seattle Children's Hospital
    Collaborators
    Actelion
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00981591
    Brief Title
    Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No patients recruited
    Study Start Date
    September 2009 (undefined)
    Primary Completion Date
    March 2013 (Actual)
    Study Completion Date
    March 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seattle Children's Hospital
    Collaborators
    Actelion

    4. Oversight

    Data Monitoring Committee
    Yes

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn, Congenital Heart Defects, Acute Respiratory Distress Syndrome
    Keywords
    Iloprost, Nitric oxide, Mechanical ventilator

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Inhaled Iloprost
    Arm Type
    Experimental
    Arm Title
    Inhaled Placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Iloprost
    Other Intervention Name(s)
    Ventavis
    Intervention Description
    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
    Intervention Name(s)
    Placebo
    Intervention Description
    Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
    Primary Outcome Measure Information:
    Title
    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
    Secondary Outcome Measure Information:
    Title
    Time to wean off iNO.
    Time Frame
    When the participant is successfully weaned off study drug
    Title
    Time to extubation.
    Time Frame
    When the participant is successfully weaned off study drug
    Title
    Total cost of iNO.
    Time Frame
    When the participant is successfully weaned off study drug
    Title
    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
    Title
    Time to ICU discharge
    Time Frame
    When the participant is successfully weaned off study drug.

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    21 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Delphine Yung, MD
    Organizational Affiliation
    Seattle Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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