Kidney Failure, Acute
Conditions
Keywords
cardiopulmonary bypass, pediatric cardiac surgery, acute renal failure, renal biomarkers, fenoldopam, Focus on optimization of perfusion during pediatric CPB
Brief summary
The purpose of this study is to determine whether fenoldopam infusion during cardiopulmonary bypass in young children with congenital heart disease is able to reduce indicators of acute kidney injury (biomarkers reduction, diuresis increase) compared to a control group.
Interventions
DRUGPlacebo
Saline continuous infusion during cardiopulmonary by pass at 1 ml/h
DRUGFenoldopam
Fenoldopam continuous infusion at 1 mcg/kg/min during cardiopulmonary bypass. Infusion preparation is mad in order to match the rate 1 ml/h of placebo infusion.
Sponsors
Bambino Gesù Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
1 Days to 365 Days
Healthy volunteers
No
Inclusion criteria
* Children with congenital heart disease, less than one year old, undergoing surgery with the use of cardiopulmonary bypass
Exclusion criteria
* Children over one year old, correction for ventricular or atrial septal defect, need for deep hypothermic circulatory arrest, preoperative renal dysfunction.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of urinary and/or serum levels of biomarker NGAL in treated group versus controls | End of surgery and 12 hours postoperatively |
Secondary
| Measure | Time frame |
|---|---|
| Reduction of urinary and/or serum levels of cystatin C, increase of diuresis and improvement of perfusion markers in treated group versus controls | End of surgery and 12 hours postoperatively |
Countries
Italy
Outcome results
None listed