Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass (VANCOCEF)
January 13, 2020 updated by: Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Roma, Italy, 00165
- Terapia Intenisva Cardiochirurgica
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
vancomycin and cefoxitin pharmacokinetics
This is surgical prophylaxis and cefoxitin/vancomycin have to be administered to each patient of the study, before surgery
|
vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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)
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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)
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Ultrafiltrate sample will be withdrawn at the end of CPB (UF1)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2017
Primary Completion (ACTUAL)
December 20, 2017
Study Completion (ACTUAL)
July 1, 2019
Study Registration Dates
First Submitted
July 10, 2016
First Submitted That Met QC Criteria
July 20, 2016
First Posted (ESTIMATE)
July 21, 2016
Study Record Updates
Last Update Posted (ACTUAL)
January 14, 2020
Last Update Submitted That Met QC Criteria
January 13, 2020
Last Verified
January 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- vanco and cefoxitin during CPB
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.