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Surgical Site Infection Study (SSI)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Todd Kilbaugh, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT01449669
First received: September 26, 2011
Last updated: January 31, 2012
Last verified: January 2012
History of Changes
  Purpose

The purpose of this study is to investigate the pharmacokinetics of cefazolin using both plasma and microdialysate sampling methods in children with single ventricle physiology undergoing their second palliation procedure. This will provide data to determine if the current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue concentrations greater than the minimum inhibitory concentrations (MIC) for common post-surgical pathogens that cause Surgical Site Infections (SSIs).


Condition
Cava-pulmonary Anastomosis

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Skeletal Muscle and Plasma Concentrations of Cefazolin During Pediatric Cardiac Surgery Utilizing Cardiopulmonary Bypass, Deep Hypothermic Cardiac Arrest, and Modified Ultrafiltration

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Hospital of Philadelphia:

Primary Outcome Measures:
  • Pharmacokinetics of Cefazolin [ Time Frame: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose. ] [ Designated as safety issue: No ]
    Composite (or Profile) of Pharmacokinetics


Secondary Outcome Measures:
  • Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle [ Time Frame: One Year ] [ Designated as safety issue: Yes ]
    • Investigate the effects of CPB, DHCA, and MUF on tissue distribution of cefazolin
    • Determine the concentration of cefazolin in IF of skeletal muscle at different stages of cardiac surgery and compare these values to concentrations of cefazolin needed to be effective against common bacterial organisms causing SSIs
    • Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle.
    • Assess the safety of the use of microdialysis method during pediatric cardiac surgery


Estimated Enrollment: 15
Study Start Date: September 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

This study aims to sample interstitial fluid (IF) of infants undergoing superior cava-pulmonary anastomosis (either Glenn or Hemi-Fontan) cardiac surgical procedures who receive cefazolin as their surgical prophylactic antibiotic. Cefazolin concentrations will then be determined in both microdialysate and plasma samples and used to define the pharmacokinetics of cefazolin at the tissue level and compare that to plasma pharmacokinetics. In addition, the data gathered will be used to assess how cardiopulmonary bypass (CPB), deep hypothermic cardiac arrest (DHCA), and modified ultrafiltration (MUF) affect tissue penetration of the prophylactically administered cefazolin.

The study involves the use of microdialysis (MD) and plasma sampling methods to determine the pharmacokinetic properties of cefazolin when used as a prophylactic antibiotic during the second palliation procedure (superior vena cava-pulmonary anastomosis) for infants with single ventricle physiology. This requires the use of microdialysis (MD) catheters inserted into the left deltoid muscle in eligible subjects after the induction of general anesthesia as well as collection of microdialysate and blood samples throughout the duration of the procedure. Cefazolin will be administered as standard of care. Cefazolin concentrations in the collected samples will be measured via a validated high-performance liquid chromatography (HPLC) and mass spectrometry assay. Pharmacokinetic analyses will be performed.

  Eligibility

Ages Eligible for Study:   3 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)

Criteria

Inclusion Criteria:

  • Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
  • Use of cefazolin as the prophylactic antibiotic during the operation
  • Written informed consent provided by the parent or legal guardian

Exclusion Criteria:

  • Use of prophylactic antibiotic other than cefazolin during the operation
  • Anatomic or other abnormalities of the upper arm that would preclude insertion of a microdialysis catheter
  • Known renal or hepatic function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01449669

Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
Principal Investigator: Todd Kilbaugh, MD Children's Hospital of Philadelphia
  More Information

Publications:

Responsible Party: Todd Kilbaugh, Attending Physician, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01449669     History of Changes
Other Study ID Numbers: 11-007976, PSSIMD
Study First Received: September 26, 2011
Last Updated: January 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Children's Hospital of Philadelphia:
pharmacokinetics
cefazolin
microdialysis sampling
interstitial fluid
 skeletal muscle
plasma
children

Additional relevant MeSH terms:
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013