Trial | NCT01598441  Report issue

Title

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)

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    iloprost water ...

  • Study Participants

    8
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.
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.
Study Started
Jun 30
2012
Primary Completion
Nov 30
2016
Study Completion
Nov 30
2016
Last Update
Nov 22
2016
Estimate

Drug iloprost nebuliser solution

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

  • Other names: Ventavis

Drug distilled water

1-2 ml aerosolized distilled water inhalation per session

  • Other names: Treeful

iloprost Experimental

Iloprost nebuliser solution 500 ng/kg inhaled

distilled water Placebo Comparator

aerosolized distilled water 1-2 ml

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
No Results Posted