Oxidative Stress in children undergoing cardiopulmonary bypass: A trial of Sildenafil therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004171-37-GB

Enrollment

Registered

2005-11-24

Start date

2006-08-02

Completion date

Unknown

Last updated

2020-07-27

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: Viagra Product Name: Sildenafil Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Gastroenteral liquid* Route of administration of the placebo: Gastroenteral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All infants less than one year of age sheduled to undergo cardiac surgery for congenital heart disease requiring cardiopulmonary bypass at the Bristol Royal Hospital for Children. 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: Children greater than one year of age. Severe hypotension pre-operatively. Absence of or refusal of parental consent. Infant already receiving sildenafil pre-operatively.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether administration of sildenafil pre-cardiopulmonary bypass reduces oxidative stress and improves outcome.;Secondary Objective: ;Primary end point(s): Blood levels of Isoprostane and nitrotyrosine to see if sildenafil reduces these markers of oxidative stress. Blood levels of nitrates and nitrites to see if sildenafil is effective at increasing endogenous nitric oxide. Length of mechanical ventilation, inotrope infusion score and length of intensive care admission to see if sildenafil improves clinical outcome.	—

Measure

Time frame

Main Objective: To determine whether administration of sildenafil pre-cardiopulmonary bypass reduces oxidative stress and improves outcome.;Secondary Objective: ;Primary end point(s): Blood levels of Isoprostane and nitrotyrosine to see if sildenafil reduces these markers of oxidative stress. Blood levels of nitrates and nitrites to see if sildenafil is effective at increasing endogenous nitric oxide. Length of mechanical ventilation, inotrope infusion score and length of intensive care admission to see if sildenafil improves clinical outcome.

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Countries

United Kingdom

Outcome results

None listed

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