Completed

NCT Number: NCT01449669

Surgical Site Infection Study

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).

Completed

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Key information

Conditions

Cava-pulmonary Anastomosis

Age range

3 month–6 month

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Pharmacokinetics of Cefazolin

Time frame: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.

Composite (or Profile) of Pharmacokinetics

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Registry information

Official study title

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

Acronym: SSI

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2014
First posted: Oct 10, 2011
Registry last updated: Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.