- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01598441
Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
November 20, 2016 updated by: Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
Multi-centre, Randomized Study of Iloprost Inhaled in Preventing and Treating Reactive Pulmonary Hypertension (RPH) and Pulmonary Hypertensive Crisis (PHC) After Repair of Congenital Heart Diseases (CHD)
This study was designed to investigate treatment of postoperative pulmonary hypertension by iloprost inhalation in children with congenital heart defects.
It was a controlled single-blind randomized multi-center prospective study in order to explore the efficacy of this method in the treatment and prevention of pediatric pulmonary hypertension after corrective open-heart surgery for congenital heart defects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Primary objectives:
- To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
- To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.
Secondary objectives:
- To investigate the preventive effect of iloprost inhaled on the life-threatening PHC occurring immediately after complex congenital heart surgery or occurring just after weaning off cardiopulmonary bypass.
- To explore the potential of iloprost inhaled to reduce the early mortality after PHC and to decrease the use of ECMO/VAD.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Shanghai, China, 200127
- Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
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Guangdong
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Guangzhou, Guangdong, China, 510000
- Guangzhou Children's Hospital
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Hubei
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Wuhan, Hubei, China, 430022
- Wuhan Asia Hear Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 week to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- CHD children who have associated PH risk factors and have accepted biventricular repair
- Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)
Exclusion Criteria:
- severe mitral stenosis
- obstructive drainage of pulmonary veins
- platelet count < 50,000,000,000/L & obvious bleeding
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: iloprost
Iloprost nebuliser solution 500 ng/kg inhaled
|
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
Other Names:
|
Placebo Comparator: distilled water
aerosolized distilled water 1-2 ml
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1-2 ml aerosolized distilled water inhalation per session
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The total incidence of RPH, PHC or death
Time Frame: within 48 hours after surgery
|
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur:
|
within 48 hours after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from base line of pulmonary hemodynamic measurements
Time Frame: within 48 hours after surgery
|
|
within 48 hours after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zhuomin Xu, PhD, Shanghai Jiao Tong University School of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
November 1, 2016
Study Completion (Actual)
November 1, 2016
Study Registration Dates
First Submitted
May 6, 2012
First Submitted That Met QC Criteria
May 14, 2012
First Posted (Estimate)
May 15, 2012
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
November 20, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SCMCIRB-201127
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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