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:

  1. To evaluate the effect of iloprost inhaled on postoperative PH after biventricular repair for CHD.
  2. To verify the benefits of iloprost inhaled in improving the hemodynamics after biventricular repair for CHD.

Secondary objectives:

  1. 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.
  2. 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

  • China
      • Shanghai, China, 200127
        • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangzhou Children's Hospital
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Wuhan Asia Hear Hospital

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
Drug: iloprost nebuliser solution
Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
Other Names:
  • Ventavis
Placebo Comparator: distilled water
aerosolized distilled water 1-2 ml
Drug: distilled water
1-2 ml aerosolized distilled water inhalation per session
Other Names:
  • Treeful

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:

  • RPH lasting for more than 30 mintues; or
  • PHC at any time; or
  • death
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
  • Pp/Ps
  • NYHA class function
  • SvO2
  • PAO2
within 48 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

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

Keywords

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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