Clinical trial NCT02839486: Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass
Official title: Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Heart Disease
Keywords: antibiotic prophylaxis
pharmacokinetics
cardiopulmonary bypass
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2016-07-21
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: vancomycin and cefoxitin concentration change in serial plasmatic samples
timeFrame: samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery.
Secondary outcomes:
measure: 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
timeFrame: samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2).
measure: vancomycin and cefoxitin clearance by ultrafiltration
timeFrame: Ultrafiltrate sample will be withdrawn at the end of CPB (UF1)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Terapia Intenisva Cardiochirurgica
Study officials:
affiliation: Bambino Gesù Hospital
name: zaccaria ricci, MD
role: PRINCIPAL_INVESTIGATOR
References: