search
Back to results

Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
iloprost nebuliser solution
distilled water
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, pulmonary hypertensive crisis

Eligibility Criteria

7 Days - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Guangzhou Children's Hospital
  • Wuhan Asia Hear Hospital
  • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

iloprost

distilled water

Arm Description

Iloprost nebuliser solution 500 ng/kg inhaled

aerosolized distilled water 1-2 ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from base line of pulmonary hemodynamic measurements
Pp/Ps NYHA class function SvO2 PAO2

Full Information

First Posted
May 6, 2012
Last Updated
November 20, 2016
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
search

1. Study Identification

Unique Protocol Identification Number
NCT01598441
Brief Title
Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, pulmonary hypertensive crisis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
iloprost
Arm Type
Experimental
Arm Description
Iloprost nebuliser solution 500 ng/kg inhaled
Arm Title
distilled water
Arm Type
Placebo Comparator
Arm Description
aerosolized distilled water 1-2 ml
Intervention Type
Drug
Intervention Name(s)
iloprost nebuliser solution
Other Intervention Name(s)
Ventavis
Intervention Description
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
Intervention Type
Drug
Intervention Name(s)
distilled water
Other Intervention Name(s)
Treeful
Intervention Description
1-2 ml aerosolized distilled water inhalation per session
Primary Outcome Measure Information:
Title
The total incidence of RPH, PHC or death
Description
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
Time Frame
within 48 hours after surgery
Secondary Outcome Measure Information:
Title
Change from base line of pulmonary hemodynamic measurements
Description
Pp/Ps NYHA class function SvO2 PAO2
Time Frame
within 48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuomin Xu, PhD
Organizational Affiliation
Shanghai Jiao Tong University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangzhou Children's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Facility Name
Wuhan Asia Hear Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430022
Country
China
Facility Name
Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
City
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

Learn more about this trial

Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension After Repair of Congenital Heart Diseases (CHD)

We'll reach out to this number within 24 hrs