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Withdrawn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
About this trial
This is an interventional treatment trial for Pulmonary Hypertension focused on measuring Iloprost, Nitric oxide, Mechanical ventilator
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
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
NCT ID
NCT00981591
First Posted
September 18, 2009
Last Updated
January 15, 2015
Sponsor
Seattle Children's Hospital
Collaborators
Actelion
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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