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

Phase 1

• Conditions: Congenital Heart Disease

• Registration Number: EUCTR2005-004171-37-GB
• Lead Sponsor: nited Bristol Healthcare Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-11-24
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

Children greater than one year of age.
Severe hypotension pre-operatively.
Absence of or refusal of parental consent.
Infant already receiving sildenafil pre-operatively.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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.<br>Blood levels of nitrates and nitrites to see if sildenafil is effective at increasing endogenous nitric oxide.<br>Length of mechanical ventilation, inotrope infusion score and length of intensive care admission to see if sildenafil improves clinical outcome.