Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
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)
1 other identifier
interventional
8
1 country
3
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2012
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2012
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 22, 2016
January 1, 2016
4.4 years
May 6, 2012
November 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The total incidence of RPH, PHC or death
The primary effective endpoints are reached when any individual components of the primary composite endpoint occur: * RPH lasting for more than 30 mintues; or * PHC at any time; or * death
within 48 hours after surgery
Secondary Outcomes (1)
Change from base line of pulmonary hemodynamic measurements
within 48 hours after surgery
Study Arms (2)
iloprost
EXPERIMENTALIloprost nebuliser solution 500 ng/kg inhaled
distilled water
PLACEBO COMPARATORaerosolized distilled water 1-2 ml
Interventions
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
1-2 ml aerosolized distilled water inhalation per session
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- severe mitral stenosis
- obstructive drainage of pulmonary veins
- platelet count \< 50,000,000,000/L \& obvious bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Guangzhou Children's Hospital
Guangzhou, Guangdong, 510000, China
Wuhan Asia Hear Hospital
Wuhan, Hubei, 430022, China
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
Shanghai, 200127, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhuomin Xu, PhD
Shanghai Jiao Tong University School of Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of ICU, Department of thoracic and cardiovascular surgery, Shanghai Children's Medical Center
Study Record Dates
First Submitted
May 6, 2012
First Posted
May 15, 2012
Study Start
June 1, 2012
Primary Completion
November 1, 2016
Study Completion
November 1, 2016
Last Updated
November 22, 2016
Record last verified: 2016-01