Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

Congenital Heart Disease Clinical Trial

— VANCOCEF  

Official title:

Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02839486
• Other study ID #: vanco and cefoxitin during CPB
• Status: Completed
• Start date: October 1, 2017
• Est. completion date: July 1, 2019

Study information

• Verified date: January 2020
• Source: Bambino Gesù Hospital and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 1, 2019
• Est. primary completion date: December 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

1. Elective cardiac surgery schedule with the planned application of CPB

2. Parents of neonates, or their legal representative, able to consent and comply with protocol requirements.

Exclusion Criteria:

1. Urgent or emergent surgery

2. Antibiotic therapy (any) administered before surgery

3. Patients receiving, before surgery, any other ofr of extracorporeal treatment (i.e extracorporeal membrane oxygenation, continuous renal replacement therapy)

4. Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.

5. Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)

6. extremely low birth weight neonates.

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Diseases

Intervention

Other:
• vancomycin pharmacokinetics
vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
• cefoxitin pharmacokinetics
cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations

Locations

Country	Name	City	State
Italy	Terapia Intenisva Cardiochirurgica	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Bambino Gesù Hospital and Research Institute

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vancomycin and cefoxitin concentration change in serial plasmatic samples	a 4-points pharmacokinetic curve per each antibiotic will be generated by serial average plasmatic vancomycin and cefoxitin concentration assessments.	samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery.
Secondary	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		samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2).
Secondary	vancomycin and cefoxitin clearance by ultrafiltration	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)	Ultrafiltrate sample will be withdrawn at the end of CPB (UF1)