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

Last updated: November 20, 2016
Sponsor: Shanghai Jiao Tong University School of Medicine
Overall Status: Completed

Phase

3

Condition

High Blood Pressure (Hypertension)

Stress

Lung Injury

Treatment

N/A

Clinical Study ID

NCT01598441
SCMCIRB-201127
  • Ages < 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • CHD children who have associated PH risk factors and have accepted biventricularrepair

  • Pp/Ps >= 0.75 (before surgery) or Pp/Ps >= 0.5 (after surgery)

Exclusion

Exclusion Criteria:

  • severe mitral stenosis

  • obstructive drainage of pulmonary veins

  • platelet count < 50,000,000,000/L & obvious bleeding

Study Design

Total Participants: 8
Study Start date:
June 01, 2012
Estimated Completion Date:
November 30, 2016

Study 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.

Connect with a study center

  • Guangzhou Children's Hospital

    Guangzhou, Guangdong 510000
    China

    Site Not Available

  • Wuhan Asia Hear Hospital

    Wuhan, Hubei 430022
    China

    Site Not Available

  • Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

    Shanghai, 200127
    China

    Site Not Available

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