Skip to main content
OpenTrials
Completed

NCT Number: NCT02839486

Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Terapia Intenisva Cardiochirurgica

Roma, 00165, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective cardiac surgery schedule with the planned application of CPB
  • Parents of neonates, or their legal representative, able to consent and comply with protocol requirements.

Exclusion criteria

  • Urgent or emergent surgery
  • Antibiotic therapy (any) administered before surgery
  • Patients receiving, before surgery, any other ofr of extracorporeal treatment (i.e extracorporeal membrane oxygenation, continuous renal replacement therapy)
  • Previous renal or hepatic dysfunction requiring need for antibiotic posology modification.
  • Surgery requiring antibiotic prophylaxis with different drug combinations (i.e vancomycin and gentamycin)
  • extremely low birth weight neonates.

Treatment and study plan

vancomycin pharmacokinetics

Other

vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations

cefoxitin pharmacokinetics

Other

cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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)

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass

Acronym: VANCOCEF

Important dates

Study start
2017
Primary completion
2017
Study completion
2019
First posted
Jul 21, 2016
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.