Surgical Site Infection Study (SSI)

February 7, 2014 updated by: Children's Hospital of Philadelphia

Skeletal Muscle and Plasma Concentrations of Cefazolin During Pediatric Cardiac Surgery Utilizing Cardiopulmonary Bypass, Deep Hypothermic Cardiac Arrest, and Modified Ultrafiltration

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

14

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

3 months to 6 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of Cefazolin
Time Frame: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.
Composite (or Profile) of Pharmacokinetics
predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle
Time Frame: One Year
  • 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
One Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Investigators

  • Principal Investigator: Todd Kilbaugh, MD, Children's Hospital of Philadelphia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

September 1, 2011

Primary Completion (ACTUAL)

April 1, 2013

Study Completion (ACTUAL)

February 1, 2014

Study Registration Dates

First Submitted

September 26, 2011

First Submitted That Met QC Criteria

October 6, 2011

First Posted (ESTIMATE)

October 10, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

February 10, 2014

Last Update Submitted That Met QC Criteria

February 7, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 11-007976
  • PSSIMD

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.

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