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Trial record 10 of 528 for:    VANCOMYCIN

Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass (VANCOCEF)

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ClinicalTrials.gov Identifier: NCT02839486
Recruitment Status : Active, not recruiting
First Posted : July 21, 2016
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Zaccaria Ricci, Bambino Gesù Hospital and Research Institute

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.

Condition or disease Intervention/treatment
Congenital Heart Disease Other: vancomycin pharmacokinetics Other: cefoxitin pharmacokinetics

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Weeks
Official Title: Vancomycin and Cefoxitin Levels During Pediatric Cardiac Surgery With Cardiopulmonary Bypass
Actual Study Start Date : October 1, 2017
Actual Primary Completion Date : December 20, 2017
Estimated Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02839486


Locations
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Italy
Terapia Intenisva Cardiochirurgica
Roma, Italy, 00165
Sponsors and Collaborators
Bambino Gesù Hospital and Research Institute
Investigators
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Principal Investigator: zaccaria ricci, MD Bambino Gesù Hospital

Additional Information:

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Responsible Party: Zaccaria Ricci, Medical Doctor, Bambino Gesù Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT02839486     History of Changes
Other Study ID Numbers: vanco and cefoxitin during CPB
First Posted: July 21, 2016    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Zaccaria Ricci, Bambino Gesù Hospital and Research Institute:
antibiotic prophylaxis
pharmacokinetics
cardiopulmonary bypass
Additional relevant MeSH terms:
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Heart Diseases
Cardiovascular Diseases
Vancomycin
Cefoxitin
Cefotaxime
Anti-Bacterial Agents
Anti-Infective Agents