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CompletedNCT01598441Updated Nov 22, 2016

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

A Phase 3 interventional study of iloprost nebuliser solution and distilled water in Pulmonary Hypertension, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 3 sites in China. Open to participants aged 7 Days to 18 Years. Per ClinicalTrials.gov, last updated 2016-11-22.

Sponsored by Shanghai Jiao Tong University School of Medicine · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
8
Allocation
Randomized
Ages
7 Days to 18 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Pulmonary Hypertension

Keywords

  • pulmonary hypertension, pulmonary hypertensive crisis
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's enrollment of 8 is below the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Days to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • severe mitral stenosis
  • obstructive drainage of pulmonary veins
  • platelet count \< 50,000,000,000/L \& obvious bleeding
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
8 participants (actual)

Study arms

  • Experimental
    iloprost

    Iloprost nebuliser solution 500 ng/kg inhaled

    Drug: iloprost nebuliser solution

  • Placebo comparator
    distilled water

    aerosolized distilled water 1-2 ml

    Drug: distilled water

Interventions

  • Drugiloprost nebuliser solution

    Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days

    Also known as: Ventavis

  • Drugdistilled water

    1-2 ml aerosolized distilled water inhalation per session

    Also known as: Treeful

06

What researchers measure

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

    Time frame: within 48 hours after surgery

Secondary outcomes

  1. Change from base line of pulmonary hemodynamic measurements

    * Pp/Ps * NYHA class function * SvO2 * PAO2

    Time frame: within 48 hours after surgery

07

Study locations

3 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01598441
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery
Responsible party
Xu Zhuoming (Director of ICU, Department of thoracic and cardiovascular surgery, Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
May 15, 2012
Start date
Jun 2012
Primary completion
Nov 2016
Completion
Nov 2016
Last update
Nov 22, 2016

Study contacts

Zhuomin Xu, PhD
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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