[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100157378":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":44,"locations":45,"responsibleParty":57,"collaborators":44,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":44,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":44,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":44,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Shanghai Jiao Tong University School of Medicine","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"iloprost low dose group","ACTIVE_COMPARATOR","iloprost 30 ng\u002Fkg\u002Fmin inhalation for 10 minutes,q4h in day time and q6h at night for 2 days",[13],"Drug: iloprost nebuliser solution",{"label":15,"type":10,"description":16,"interventionNames":17},"iloprost high dose group","iloprost 50 ng\u002Fkg\u002Fmin inhalation for 10 minutes, q4h in day time and q6h at night for 2 days",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"placebo group","PLACEBO_COMPARATOR","distilled water 2 ml per session",[23],"Drug: distilled water",[25,31,34],{"type":26,"name":27,"description":11,"armGroupLabels":28,"otherNames":29},"DRUG","iloprost nebuliser solution",[9],[30],"Ventavis",{"type":26,"name":27,"description":16,"armGroupLabels":32,"otherNames":33},[15],[30],{"type":26,"name":35,"description":21,"armGroupLabels":36,"otherNames":37},"distilled water",[19],[38],"Treeful",[40],{"name":41,"affiliation":42,"role":43},"Zhuo-ming Xu, MD,PhD","Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center","STUDY_DIRECTOR",null,[46],{"facility":42,"status":44,"city":47,"state":44,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":44},"Shanghai","200127","China","CN",{"type":52,"coordinates":53},"Point",[54,55],121.45806,31.22222,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Xu Zhuoming","Director of Cardiac intensive Care Unit,Department of Thoracic and Cardiovascular Sugery,Shanghai Children's Medical Center.","100157378","phase-2-study-of-inhaled-iloprost-for-the-treatment-of-pulmonary-hypertension-after-repair-of-congenital-heart-disease-100157378",false,"NCT01320878","Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease","A Randomized Controlled Study of Inhaled Iloprost for the Treatment of Pulmonary Hypertension After Repair of Congenital Heart Disease","Inclusion Criteria:\n\nBefore corrective procedure for CHD, two of bellow ten criteria should be met:\n\n* Decreased respiratory infection \\& decreased exercise tolerance\n* Pulse SaO2 \\\u003C 93% in left-right shunt CHD case (in room air)\n* EKG: right ventricular hypertrophy, right atrial dilatation\n* Chest X-ray: enhanced vascular signs in trans-hilar, loss of blood vessel in bilateral lung fields, pulmonary arterial trunk dilatation, right ventricular enlargement\n* Cardiac echocardiography: fast tricuspid or pulmonary valve regurgitant velocity, ventricular and aortic level bidirectional shunt, or even right-to-left shunt\n* Underfilling of pulmonary capillary, 'pruning' of the peripheral blood vessels\n* Pp\u002FPs \\> 0.75\n* Qp\u002FQs \\\u003C1.5\n* PVR \\> 9WU\u002Fm2\n* Rp\u002FRs \\> 0.5\n\nExclusion Criteria:\n\n* a body weight of \\\u003C 2 kg,\n* prematurity (birth 36 weeks postconceptual age)\n* renal dysfunction (creatinine \\>= 1.5 mg\u002FdL 48 hours before surgery)\n* PLT \\\u003C 50,000\\*109\u002FL and obvious bleeding\n* LCOS or hypotension on arrival to the intensive care unit\n\nAfter corrective procedure for CHD:\n\n* deficient anatomy associated with remained intracardiac shunts and severe artrio-ventricular regurgitation\n* severe arrhythmia led to low cardiac output","ALL","4 Years","12 Years",{"count":72,"type":73},64,"ACTUAL","INTERVENTIONAL",[76],"PHASE2","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.",[79],"Pulmonary Hypertension",[81],"pulmonary hypertension","COMPLETED","2012-06-15",{"date":85,"type":86},"2012-06-18","ESTIMATED",{"date":88,"type":44},"2007-10",{"date":90,"type":73},"2009-12",{"name":5,"class":6},1]