Examination of the effectiveness of sildenafil in preventing lung vesselconstriction after heart surgery in childre

• Conditions: Ventriculs septal defect, atrioventricular canal with pulmonaryhypertension; MedDRA version: 14.1Level: HLTClassification code 10010401Term: Congenital cardiovascular anomaly therapeutic proceduresSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2011-005440-98-AT
• Lead Sponsor: AKH Linz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-07
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Ventricular septal defect, AV-Canal with pulmonary hypertension
informed parental consent
age 0-2 years

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

additional structural abnormalities affecting pulmonary resistance
ventilation preoperatively
residual VSD
high dosage of catecholamines, hemodynamic instability
extracorporeal technics
abnormalities of oesophagus with contraindication for transoesophegeal
Doppler

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Frequency of pulmonary hypertensive crises;Secondary Objective: mean pulmonary artery pressure<br>cardiac output by transoesophageal Doppler<br>fluid balance<br>length of ventilation<br>length of ICU stay<br>;Primary end point(s): number of pulmonary hypertensive crises;Timepoint(s) of evaluation of this end point: 0,6,12,24,36,48 hours after admission

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): mean pulmonary pressure<br>fluid balance<br>cardiac output<br>duration of ventilation<br>duration of ICU stay<br>German;Timepoint(s) of evaluation of this end point: 0,6,12,24,36,48 hours after admission