Surgical Site Infection Study
Information source: Children's Hospital of Philadelphia
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cava-pulmonary Anastomosis
Phase: N/A
Status: Completed
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s): Todd Kilbaugh, MD, Principal Investigator, Affiliation: Children's Hospital of Philadelphia
Summary
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).
Clinical Details
Official title: Skeletal Muscle and Plasma Concentrations of Cefazolin During Pediatric Cardiac Surgery Utilizing Cardiopulmonary Bypass, Deep Hypothermic Cardiac Arrest, and Modified Ultrafiltration
Study design: Observational Model: Cohort
Primary outcome: Pharmacokinetics of Cefazolin
Secondary outcome: Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle
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
Minimum age: 3 Months.
Maximum age: 6 Months.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Related publications: Centers for Disease Control and Prevention (CDC). Division of Healthcare Quality Promotion (DHPQ). Estimates of Healthcare-Associated Infections. March 12, 2010. Available at: http://www.cdc.gov/ncidod/dhqp/hai.html. Accessed August 3, 2010. Anderson DJ, Kaye KS, Classen D, Arias KM, Podgorny K, Burstin H, Calfee DP, Coffin SE, Dubberke ER, Fraser V, Gerding DN, Griffin FA, Gross P, Klompas M, Lo E, Marschall J, Mermel LA, Nicolle L, Pegues DA, Perl TM, Saint S, Salgado CD, Weinstein RA, Wise R, Yokoe DS. Strategies to prevent surgical site infections in acute care hospitals. Infect Control Hosp Epidemiol. 2008 Oct;29 Suppl 1:S51-61. doi: 10.1086/591064. Sparling KW, Ryckman FC, Schoettker PJ, Byczkowski TL, Helpling A, Mandel K, Panchanathan A, Kotagal UR. Financial impact of failing to prevent surgical site infections. Qual Manag Health Care. 2007 Jul-Sep;16(3):219-25. Costello JM, Graham DA, Morrow DF, Morrow J, Potter-Bynoe G, Sandora TJ, Pigula FA, Laussen PC. Risk factors for surgical site infection after cardiac surgery in children. Ann Thorac Surg. 2010 Jun;89(6):1833-41; discussion 1841-2. doi: 10.1016/j.athoracsur.2009.08.081. Ben-Ami E, Levy I, Katz J, Dagan O, Shalit I. Risk factors for sternal wound infection in children undergoing cardiac surgery: a case-control study. J Hosp Infect. 2008 Dec;70(4):335-40. doi: 10.1016/j.jhin.2008.08.010. Epub 2008 Oct 31. Holzmann-Pazgal G, Hopkins-Broyles D, Recktenwald A, Hohrein M, Kieffer P, Huddleston C, Anshuman S, Fraser V. Case-control study of pediatric cardiothoracic surgical site infections . Infect Control Hosp Epidemiol. 2008 Jan;29(1):76-9. doi: 10.1086/524323. Kagen J, Lautenbach E, Bilker WB, Matro J, Bell LM, Dominguez TE, Gaynor JW, Shah SS. Risk factors for mediastinitis following median sternotomy in children. Pediatr Infect Dis J. 2007 Jul;26(7):613-8. Allpress AL, Rosenthal GL, Goodrich KM, Lupinetti FM, Zerr DM. Risk factors for surgical site infections after pediatric cardiovascular surgery. Pediatr Infect Dis J. 2004 Mar;23(3):231-4. Nateghian A, Taylor G, Robinson JL. Risk factors for surgical site infections following open-heart surgery in a Canadian pediatric population. Am J Infect Control. 2004 Nov;32(7):397-401. Mehta PA, Cunningham CK, et al. Risk factors for sternal wound and other infections in pediatric cardiac surgical patients. Pediatr Infect Dis J 2000;19:1000-1004. 12. Sarvikivi E, Lyytikainen O, et al. Nosocomial infections after pediatric cardiac surgery. Am J Infect Control 2008;36:564-569.
Starting date: September 2011
Last updated: February 7, 2014
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