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Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease

Sponsor
Shanghai Jiao Tong University School of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01320878
Collaborator
(none)
64
Enrollment
1
Location
3
Arms
26
Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The objective of this study was to assess the efficacy and appropriate dose of iloprost for inhalation in the treatment of postoperative pulmonary hypertension in children with congenital heart defects.

Condition or Disease Intervention/Treatment Phase
  • Drug: iloprost nebuliser solution
  • Drug: iloprost nebuliser solution
  • Drug: distilled water
 Phase 2

Detailed Description

Pulmonary hypertension is a serious postoperative complication in children with congenital heart defects, which has a high incidence and mortality. Iloprost is a prostacyclin analogue. When applied by inhalation, it selectively dilates pulmonary vessels, without side affecting the systemic circulation. No randomized controlled trials (RCT) of iloprost have previously been performed in this indication. The investigators study is the first RCT of iloprost for inhalation after surgery of children's congenital heart diseases to be performed in this field.

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Jul 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: iloprost low dose group

iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days

Drug: iloprost nebuliser solution
iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
Other Names:
  • Ventavis

    		•
    Active Comparator: iloprost high dose group

    iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days

    Drug: iloprost nebuliser solution
    iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
    Other Names:
  • Ventavis

    		•
    Placebo Comparator: placebo group

    distilled water 2 ml per session

    Drug: distilled water
    distilled water 2 ml per session
    Other Names:
  • Treeful

    		•

    Outcome Measures

    Primary Outcome Measures

    1. all cause pulmonary artery pressure [one year]

    Secondary Outcome Measures

    1. central venous pressure [one year]

    2. blood pressure [one year]

    3. cardiac index [one year]

    4. pulmonary vascular resistance [one year]

    5. mortality [one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    4 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    Before corrective procedure for CHD, two of bellow ten criteria should be met:

    • Decreased respiratory infection & decreased exercise tolerance

    • Pulse SaO2 < 93% in left-right shunt CHD case (in room air)

    • EKG: right ventricular hypertrophy, right atrial dilatation

    • Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement

    • Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt

    • Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels

    • Pp/Ps > 0.75

    • Qp/Qs <1.5

    • PVR > 9WU/m2

    • Rp/Rs > 0.5

    Exclusion Criteria:

    • a body weight of < 2 kg,

    • prematurity (birth 36 weeks postconceptual age)

    • renal dysfunction (creatinine >= 1.5 mg/dL 48 hours before surgery)

    • PLT < 50,000*109/L and obvious bleeding

    • LCOS or hypotension on arrival to the intensive care unit

    After corrective procedure for CHD:

    • deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation

    • severe arrhythmia led to low cardiac output

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center Shanghai China 200127

    Sponsors and Collaborators

    • Shanghai Jiao Tong University School of Medicine

    Investigators

    • Study Director: Zhuo-ming Xu, MD,PhD, Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xu Zhuoming, Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center., Shanghai Jiao Tong University School of Medicine
    ClinicalTrials.gov Identifier:
    NCT01320878
    Other Study ID Numbers:
    • SJTUMS-10-16
    First Posted:
    Mar 23, 2011
    Last Update Posted:
    Jun 18, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Xu Zhuoming, Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center., Shanghai Jiao Tong University School of Medicine
    pulmonary hypertension
    Additional relevant MeSH terms:
    Hypertension, Pulmonary
    Hypertension
    Heart Diseases
    Heart Defects, Congenital
    Iloprost
    Pharmaceutical Solutions

    Study Results

    No Results Posted as of Jun 18, 2012