Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass (VANCOCEF)
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|ClinicalTrials.gov Identifier: NCT02839486|
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : June 8, 2018
|Condition or disease||Intervention/treatment|
|Congenital Heart Disease||Other: vancomycin pharmacokinetics Other: cefoxitin pharmacokinetics|
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||40 participants|
|Target Follow-Up Duration:||4 Weeks|
|Official Title:||Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass|
|Actual Study Start Date :||October 1, 2017|
|Actual Primary Completion Date :||December 20, 2017|
|Estimated Study Completion Date :||July 1, 2018|
vancomycin and cefoxitin pharmacokinetics
This is surgical prophylaxis and cefoxitin/vancomycin have to be administered to each patient of the study, before surgery
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
- vancomycin and cefoxitin concentration change in serial plasmatic samples [ Time Frame: samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery. ]a 4-points pharmacokinetic curve per each antibiotic will be generated by serial average plasmatic vancomycin and cefoxitin concentration assessments.
- differences between pre-determined subgroups (neonates, infants, children weighting less than 40 kg and children weighting more than 40 kg) in plasmatic vancomycin and cefoxitin levels change at each time point [ Time Frame: samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2). ]
- vancomycin and cefoxitin clearance by ultrafiltration [ Time Frame: Ultrafiltrate sample will be withdrawn at the end of CPB (UF1) ]The clearance of vancomycin and cefoxitin in the ultrafiltrate (UF) will be evaluated. Antibiotics' sieving coefficient (SC) will be calculated from antibiotics concentrations at the following time points: UF1/[(CPB1+CPB2)/2]. Antibiotics clearance will be calculated as SC*UF rate (ml/min)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839486
|Terapia Intenisva Cardiochirurgica|
|Roma, Italy, 00165|
|Principal Investigator:||zaccaria ricci, MD||Bambino Gesù Hospital|