Does pre-operative Sildenafil protect against pulmonary related complications following cardiopulmonary bypass? A randomised trial in children undergoing cardiac surgical repair

Phase 1

• Conditions: Congenital Heart Disease

• Registration Number: EUCTR2005-001034-32-GB
• Lead Sponsor: HS Greater Glasgow, Yorkhill

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-27
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

Inclusion criteria
- pediatric patients undergoing open heart surgery utilising cardiopulmonary bypass to correct acyanotic congenital heart disease
- age >3 months
- parents that show a good understanding of their child's condition and are happy for their child to participate in the study

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

Exclusion criteria
- patients with known organ dysfunction prior to surgery (pulmonary, renal or hepatic)
- communication barriers resulting in poor basic comprehension of the proposed study (e.g. language barrier)
- patients with cyanotic heart disease
-patients undergoing heart surgery without the use of cardiopulmonary bypass
- patients who do not tolerate oral Sildenafil (e.g. Vomiting) or whose surgery is subsequently cancelled

Study & Design

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