NCT02839486

Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 40 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study will be to evaluate vancomycin and cefoxitin blood levels during elective cardiopulmonary bypass (CPB) surgery in four pre-determined pediatric strata: neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg.

Detailed description

Few data are available in current literature about pharmacokinetics (PK) of antibiotics administered as surgical prophylaxis to children scheduled for cardiac surgery with CPB. In particular, vancomycin PK during CPB has been studied only in small case series, whereas no specific study has been conducted, so far, in the specific setting of children receiving cefoxitin during CPB. CPB affects patients' volemia and drugs PK is eventually altered. On the other side during and after surgery for heart defects, many risk factors may decrease renal and hepatic clearance, including altered renal perfusion, use of vasoactive agents, and use of concomitant nephrotoxic medications. Primary Objective of the study will be: • To study the pharmacokinetic profile of vancomycin and cefoxitin administered, as antibiotic prophylaxis to children undergoing elective CPB. Secondary Objectives will be: * To evaluate if a significant difference in blood levels will occur in the four predetermined patients' categories. * To evaluate the role of hemodilution during CPB on studied antibiotics' serum concentration * To verify the incidence of post-operative infections in the studied population with particular attention to sensitive bacteria * To evaluate the impact of ultrafiltration in studied antibiotics' clearance * To evaluate safety of the administered antibiotics This is a prospective monocentric, open label, not controlled clinical trial.

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
OTHER	vancomycin pharmacokinetics	vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
OTHER	cefoxitin pharmacokinetics	cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations

Timeline

• Start date: 2017-10-01
• Primary completion: 2017-12-20
• Completion: 2019-07-01
• First posted: 2016-07-21
• Last updated: 2020-01-14

Locations

1 site across 1 country: Italy