Vancomycin and Cefoxitin During Pediatric Cardiopulmonary Bypass

NCT02839486 | Completed DMC

• 1 other identifier: vanco and cefoxitin during CPB
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Disease

Keywords

antibiotic prophylaxis; pharmacokinetics; cardiopulmonary bypass

Outcome Measures

Primary Outcomes (1)

• 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.

  samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2), at end of surgery.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

  samples will be withdrawn: at skin incision, 15 minutes after CPB start (CPB1), at the end of CPB (CPB2).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

  Ultrafiltrate sample will be withdrawn at the end of CPB (UF1)

Study Arms (1)

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; Other: cefoxitin pharmacokinetics

Interventions

vancomycin pharmacokinetics OTHER

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

vancomycin and cefoxitin pharmacokinetics

cefoxitin pharmacokinetics OTHER

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

vancomycin and cefoxitin pharmacokinetics

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children undergoing cardiac surgery requiring cardiopulmonary bypass and antibiotic prophylaxis with vancomycin and cefoxitin

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead

Study Sites (1)

Terapia Intenisva Cardiochirurgica

Roma, 00165, Italy

Location

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• zaccaria ricci, MD

  Bambino Gesù Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 10, 2016
• First Posted: July 21, 2016
• Study Start: October 1, 2017
• Primary Completion: December 20, 2017
• Study Completion: July 1, 2019
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)