Congenital Heart DiseaseVANCOCEFNCT02839486
Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass
An observational study of Congenital Heart Disease, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- vancomycin pharmacokinetics and cefoxitin pharmacokinetics
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2017to 1 Jul 2019
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease
- Being tested
- vancomycin pharmacokinetics, cefoxitin pharmacokinetics
- Keywords
- antibiotic prophylaxis, pharmacokinetics, cardiopulmonary bypass
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vancomycin pharmacokineticsOther
vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
cefoxitin pharmacokineticsOther
cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
| Study group | Role | What they receive |
|---|---|---|
| vancomycin and cefoxitin pharmacokinetics | This is surgical prophylaxis and cefoxitin/vancomycin have to be administered to each patient of the study, before surgery Receives: Other: vancomycin pharmacokinetics; Other: cefoxitin pharmacokinetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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
Measured: 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
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)
Measured: Ultrafiltrate sample will be withdrawn at the end of CPB (UF1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start1 Oct 2017
- Primary completion20 Dec 2017
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zaccaria Ricci, Bambino Gesù Hospital and Research Institute
- Investigators
- zaccaria ricci, MD, Principal investigator, Bambino Gesù Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839486
- Sponsor's protocol ID
- vanco and cefoxitin during CPB
- Acronym
- VANCOCEF
- Status last verified
- Jan 2020
- First submitted
- 10 Jul 2016
- Last updated
- 14 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02839486
- Acronym / sponsor ID
- VANCOCEF / vanco and cefoxitin during CPB
- Conditions
- Congenital Heart Disease
- Keywords
- antibiotic prophylaxis, pharmacokinetics, cardiopulmonary bypass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 21 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| vancomycin and cefoxitin pharmacokinetics | – | Other: vancomycin pharmacokinetics, Other: cefoxitin pharmacokineticsThis is surgical prophylaxis and cefoxitin/vancomycin have to be administered to each patient of the study, before surgery |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vancomycin pharmacokineticsvancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations | Other | vancomycin and cefoxitin pharmacokinetics |
| cefoxitin pharmacokineticscefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations | Other | vancomycin and cefoxitin pharmacokinetics |
Primary outcome
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.
2 secondary outcomes
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zaccaria ricci, MD principal investigator
Bambino Gesù Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.