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

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2006
INTERVENTION: Trade Name: Viagra Product Name: Sildenafil Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Gastroenteral liquid* Route of administration of the placebo: Gastroenteral use CONDITION: Congenital Heart Disease PRIMARY OUTCOME: Main Objective: To determine whether administration of sildenafil pre‐cardiopulmonary bypass reduces oxidative stress and improves outcome. 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. Secondary Objective: 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
Epistemonikos ID: 3a35ea9a1a84edadc138b5b7e2d1dd65d1c944e6
First added on: Jul 27, 2021