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Study of Inhaled Iloprost in Pediatric Pulmonary Hypertension (PH) After Surgery

NCT ID: NCT01310751

Last Updated: 2015-11-24

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

PHASE2/PHASE3

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2013-12-31

Brief Summary

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The aim of this study is to determine whether inhaled iloprost can be used to prevent and treat PH and PHC while in children after operation of CHD

Detailed Description

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Pulmonary hypertension (PH) is a significant contributor to the postoperative morbidity and mortality of congenital heart disease. Inhaled iloprost has been approved for the treatment of adults with PH, but little is known about the effects in children with PH.

Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels without side affecting the systemic circulation. There is no RCTs of iloprost have previously been performed in this indication.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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iloprost nebuliser solusion

50 ng/kg/min

Group Type EXPERIMENTAL

iloprost nebuliser solusion

Intervention Type DRUG

50 ng/kg/min inhalation for 10 minutes, q2h for 2 days

distilled water

2ml

Group Type PLACEBO_COMPARATOR

distilled water

Intervention Type DRUG

2 ml per session

Interventions

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iloprost nebuliser solusion

50 ng/kg/min inhalation for 10 minutes, q2h for 2 days

Intervention Type DRUG

distilled water

2 ml per session

Intervention Type DRUG

Other Intervention Names

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Venatvis placebo

Eligibility Criteria

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Inclusion Criteria

Before corrective procedure for CHD, two of bellow ten criteria should be met

1. Pulse SaO2 smaller than 93% in left-right shunt CHD case (in room air)
2. EKG: right ventricular hypertrophy, right atrial dilatation
3. Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessal in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement
4. Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt
5. Under-filling of pulmonary capillary, 'pruning' of the peripheral blood vessels
6. Pp/Ps greater than 0.75
7. Qp/Qs smaller than 1.5
8. PVR grater than 9 Wood Unit/m2
9. Rp/Rs graeter than 0.5

Exclusion Criteria

After corrective procedure for CHD:

1. Deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation
2. Severe arrhythmia led to low cardiac output
3. PLT smaller than 50,000\*109/L and obvious bleeding
Minimum Eligible Age

9 Days

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xu Zhuoming

chief cadiologist,Director of ICU, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xu Zhuo-ming, M.D., PhD.

Role: STUDY_DIRECTOR

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

Locations

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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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SJTUMS-200903

Identifier Type: -

Identifier Source: org_study_id