Health Condition 1: null- Ventricle Septum Defect (closure)
Conditions
Interventions
Intervention1: Sildenafil/placebo: Sildenafil upto 1.0 mg/kg of body weight / placebo (normal saline), one time infusion over 10 minutes
Intervention2: Suspension Sildenafil: Suspension Sildenafil up
Sponsors
The Department of Physiology at Maastricht University
Eligibility
Inclusion criteria
Inclusion criteria: -Children with ventricular septal defect (VSD) with pure L-R shunt (moderate pulmonary hypertension) undergoing surgical closure of the VSD. -Sex: Male and Female. -Age: -Isolated VSD without associated lesions.
Exclusion criteria
Exclusion criteria: -Critical illness -Circulatory insufficiency -Pre-existent atrioventricular block (AV-block) -Bleeding disorders --Estimated need for postoperative use of Sildenafil for severe pulmonary hypertension (VSD with severe PAH) -VSD with no PAH -Ventriculotomy approach
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Immediate postoperative course, assessed by weaning time from cardiopulmonary bypass pump and mechanical ventilation and the inotropy score, will be the primary outcome measures of the study.Timepoint: Immediate postoperative course, assessed by weaning time from cardiopulmonary bypass pump and mechanical ventilation and the inotropy score, will be the primary outcome measures of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Area under the curves of Troponin I and CK-MB release will be determined.Timepoint: Pre-operatively and 1, 6, 12, 24, 48 hours after cardiopulmonary bypass Surgery | — |
Countries
India
Contacts
Public ContactDr P V Suresh
Narayana Institute of Cardiac sciences,
Outcome results
None listed