Cava-pulmonary AnastomosisSSINCT01449669
Surgical Site Infection Study
An observational study of Cava-pulmonary Anastomosis, run by Children's Hospital of Philadelphia.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 months
- Conditions the study is for
- Cava-pulmonary Anastomosis
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 months
- All sexes
- No healthy volunteers
- Child
Study population: Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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).
Read the 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.
- Conditions
- Cava-pulmonary Anastomosis
- Keywords
- pharmacokinetics, cefazolin, microdialysis sampling, interstitial fluid, skeletal muscle, plasma, children
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics of Cefazolin
Composite (or Profile) of Pharmacokinetics
Measured: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.
Secondary outcomes (1)
Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle
- 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
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionApr 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Cava-pulmonary AnastomosisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd Kilbaugh, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449669
- Sponsor's protocol ID
- 11-007976
- Other IDs
- PSSIMD
- Acronym
- SSI
- Status last verified
- Feb 2014
- First submitted
- 26 Sep 2011
- Last updated
- 10 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
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. No abstract available.
PubMed 18840089Sparling 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. doi: 10.1097/01.QMH.0000281058.99929.ea.
PubMed 17627217Costello 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.
PubMed 20494036Ben-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.
PubMed 18951662Holzmann-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.
PubMed 18171193Kagen 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. doi: 10.1097/INF.0b013e31806166bb.
PubMed 17596804Allpress 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. doi: 10.1097/01.inf.0000114904.21616.ba.
PubMed 15014298Nateghian 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. doi: 10.1016/j.ajic.2004.03.004.
PubMed 15525914Mehta PA, Cunningham CK, Colella CB, Alferis G, Weiner LB. Risk factors for sternal wound and other infections in pediatric cardiac surgery patients. Pediatr Infect Dis J. 2000 Oct;19(10):1000-4. doi: 10.1097/00006454-200010000-00012.
PubMed 11055604
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skeletal Muscle and Plasma Concentrations of Cefazolin During Pediatric Cardiac Surgery Utilizing Cardiopulmonary Bypass, Deep Hypothermic Cardiac Arrest, and Modified Ultrafiltration
- ClinicalTrials.gov ID
- NCT01449669
- Acronym / sponsor ID
- SSI / 11-007976
- Conditions
- Cava-pulmonary Anastomosis
- Keywords
- pharmacokinetics, cefazolin, microdialysis sampling, interstitial fluid, skeletal muscle, plasma, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
Who may qualify
- Ages
- 3 to 6 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Males or females with single ventricle physiology undergoing their second palliation procedure (typically performed between 3-6 months of age)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pharmacokinetics of Cefazolin
Time frame: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.
Composite (or Profile) of Pharmacokinetics
1 secondary outcome
Investigate the relationship between cefazolin concentrations in the plasma and those at the level of IF of skeletal muscle
Time frame: One Year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
- BackgroundCenters 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.
- Background: PubMed 18840089Anderson 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. No abstract available.
- Background: PubMed 17627217Sparling 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. doi: 10.1097/01.QMH.0000281058.99929.ea.
- Background: PubMed 20494036Costello 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.
- Background: PubMed 18951662Ben-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.
- Background: PubMed 18171193Holzmann-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.
- Background: PubMed 17596804Kagen 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. doi: 10.1097/INF.0b013e31806166bb.
- Background: PubMed 15014298Allpress 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. doi: 10.1097/01.inf.0000114904.21616.ba.
- Background: PubMed 15525914Nateghian 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. doi: 10.1016/j.ajic.2004.03.004.
- Background: PubMed 11055604Mehta PA, Cunningham CK, Colella CB, Alferis G, Weiner LB. Risk factors for sternal wound and other infections in pediatric cardiac surgery patients. Pediatr Infect Dis J. 2000 Oct;19(10):1000-4. doi: 10.1097/00006454-200010000-00012.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Todd Kilbaugh, MD principal investigator
Children's Hospital of Philadelphia
Questions about this trial
What is this clinical trial studying?
An observational study of Cava-pulmonary Anastomosis, run by Children's Hospital of Philadelphia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics of Cefazolin (time frame: predose, .08,.25, .5, 1, 1.5, 2, 3, 4 hours and post dose.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01449669, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.