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NCT Number: NCT01598441

Multicenter Study of Iloprost Inhaled in Pulmonary Hypertension 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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

7 day–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guangzhou Children's Hospital, Guangzhou, Guangdong, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iloprost nebuliser solution

Drug

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

Other names: Ventavis

distilled water

Drug

1-2 ml aerosolized distilled water inhalation per session

Other names: Treeful

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from base line of pulmonary hemodynamic measurements

    Time frame: within 48 hours after surgery

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

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Collaborators

  • Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
May 15, 2012
Registry last updated
Nov 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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