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This study has been withdrawn prior to enrollment.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:
Seattle Children's Hospital
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Hypertension Neonatal Hypoxic Respiratory Failure Persistent Pulmonary Hypertension of Newborn Congenital Heart Defects Acute Respiratory Distress Syndrome |
Drug: Iloprost Drug: Placebo |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Congenital Heart Defects
Critical Care
High Blood Pressure
Pulmonary Hypertension
Respiratory Failure
U.S. FDA Resources
Further study details as provided by Seattle Children's Hospital:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Enrollment: | 0 |
| Study Start Date: | September 2009 |
| Study Completion Date: | March 2013 |
| Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Inhaled Iloprost |
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
|
| Placebo Comparator: Inhaled Placebo |
Drug: Placebo
Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more
|
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.
Eligibility| Ages Eligible for Study: | up to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Seattle Children's Hospital |
| ClinicalTrials.gov Identifier: | NCT00981591 History of Changes |
| Other Study ID Numbers: | SCIL-001-12806 |
| Study First Received: | September 18, 2009 |
| Last Updated: | March 7, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Seattle Children's Hospital:
|
Iloprost Nitric oxide Mechanical ventilator |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Hypertension Hypertension, Pulmonary Persistent Fetal Circulation Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Respiratory Insufficiency Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities Vascular Diseases Lung Diseases Respiratory Tract Diseases |
Infant, Newborn, Diseases Respiration Disorders Infant, Premature, Diseases Lung Injury Nitric Oxide Iloprost Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Free Radical Scavengers |
ClinicalTrials.gov processed this record on May 19, 2013