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

NCT ID: NCT01598441

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Keywords

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pulmonary hypertension, pulmonary hypertensive crisis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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iloprost

Iloprost nebuliser solution 500 ng/kg inhaled

Group Type EXPERIMENTAL

iloprost nebuliser solution

Intervention Type DRUG

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

distilled water

aerosolized distilled water 1-2 ml

Group Type PLACEBO_COMPARATOR

distilled water

Intervention Type DRUG

1-2 ml aerosolized distilled water inhalation per session

Interventions

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iloprost nebuliser solution

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

Intervention Type DRUG

distilled water

1-2 ml aerosolized distilled water inhalation per session

Intervention Type DRUG

Other Intervention Names

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Ventavis Treeful

Eligibility Criteria

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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
Minimum Eligible Age

7 Days

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cardiothoracic Surgical Group of Chinese Society of Pediatric Surgery

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xu Zhuoming

Director of ICU, Department of thoracic and cardiovascular surgery, Shanghai Children's Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuomin Xu, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University School of Medicine

Locations

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Guangzhou Children's Hospital

Guangzhou, Guangdong, China

Site Status

Wuhan Asia Hear Hospital

Wuhan, Hubei, China

Site Status

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

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SCMCIRB-201127

Identifier Type: -

Identifier Source: org_study_id