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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001034-32-GB

Enrollment

Registered

2006-01-27

Start date

2006-02-02

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Heart Disease

Interventions

Trade Name: Sildenafil Citrate Product Name: Sildenafil Citrate Product Code: N/A Pharmaceutical Form: Oral suspension Pharmaceutical fo

Eligibility

Sex/Gender

All

Inclusion criteria

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: 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

Design outcomes

Primary

Measure	Time frame
Main Objective: Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair of congenital heart disease?;Primary end point(s): The efficacy of pre-operative Sildenafil given to children undergoing corrective heart surgery for congenital heart disease in reducing PVRI, the systemic inflammatory response to CPB and improving oxygenation post-operatively.; Secondary Objective: To further delineate the mechanism(s) of action of Sildenafil in this setting. Specifically, does pre-operative Sildenafil: - reduce post-operative pulmonary vascular resistance index? - improve post-operative oxygenation? - affect the systemic inflammatory response to cardiopulmonary bypass?	—

Measure

Time frame

Main Objective: Does pre-operative administration of Sildenafil (Viagra, Pfizer) reduce the lung injury associated with cardiopulmonary bypass in children undergoing corrective surgical repair of congenital heart disease?;Primary end point(s): The efficacy of pre-operative Sildenafil given to children undergoing corrective heart surgery for congenital heart disease in reducing PVRI, the systemic inflammatory response to CPB and improving oxygenation post-operatively.; Secondary Objective: To further delineate the mechanism(s) of action of Sildenafil in this setting. Specifically, does pre-operative Sildenafil: - reduce post-operative pulmonary vascular resistance index? - improve post-operative oxygenation? - affect the systemic inflammatory response to cardiopulmonary bypass?

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026