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Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients

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ClinicalTrials.gov Identifier: NCT01619982
Recruitment Status : Completed
First Posted : June 15, 2012
Results First Posted : January 12, 2018
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Chandra Ramamoorthy, Stanford University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Congenital Heart Diseases
Aortic Valve Disorder
Interventions Drug: Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride
Drug: Cefazolin 30 mg/kg body weight
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30 mg/kg Body Weight
Hide Arm/Group Description

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Period Title: Overall Study
Started 20 12
Completed 20 12
Not Completed 0 0
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30 mg/kg Body Weight Total
Hide Arm/Group Description

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or at 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery. Total of all reporting groups
Overall Number of Baseline Participants 20 12 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
0 day to 12 months Number Analyzed 20 participants 12 participants 32 participants
20
 100.0%
12
 100.0%
32
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 12 participants 32 participants
Female
12
  60.0%
8
  66.7%
20
  62.5%
Male
8
  40.0%
4
  33.3%
12
  37.5%
1.Primary Outcome
Title Number of Patients Who Receive Preoperative Vancomycin and Cefazolin Who Develop a Surgical Site Infection Compared to Those Whose Received Only Cefazolin.
Hide Description Number of patients who receive preoperative vancomycin and cefazolin who develop a surgical site infection (SSI) compared to those whose received only cefazolin. Surveillance was done with standard procedures and definitions.
Time Frame Patients will be monitored for superficial SSIs for 30 days from the date of surgery. Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is present.
Hide Outcome Measure Data
Hide Analysis Population Description
Pre-operative Prophylaxis With Vancomycin and Cefazolin in Pediatric Cardiovascular Surgery Patients undergoing cardiopulmonary bypass
Arm/Group Title Cefazolin 25mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 20 12
Measure Type: Number
Unit of Measure: participants
0 0
2.Secondary Outcome
Title Cefazolin Pharmacokinetics
Hide Description Cefazolin Pharmacokinetics was measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)
Time Frame Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: L
Central Volume
0.547
(0.408 to 0.685)
Peripheral Volume (Fast)
0.102
(0.099 to 0.103)
Peripheral Volume (slow)
0.7
(0.69 to 0.71)
3.Secondary Outcome
Title Cefazolin Pharmacokinetics
Hide Description Measured as Elimination Clearance Inter-tissue Clearance (Fast) Inter-tissue Clearance(Slow)
Time Frame Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Cefazolin pharmacokinetics were assessed only in the Cefazolin 30 mg/kg Body Weight group
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 0 10
Median (95% Confidence Interval)
Unit of Measure: L/min
Elimination clearance
0.00396
(0.00393 to 0.00398)
Inter-tissue Clearance (Fast)
0.1
(0.1 to 0.102)
Inter-tissue Clearance (slow)
0.0231
(0.023 to 0.0232)
4.Secondary Outcome
Title Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children During the Peri-operative Period in Infants Undergoing Cardiac Surgery With Cardiopulmonary Bypass (CPB)
Hide Description Vancomycin pharmacokinetics measured as Central Volume, Peripheral Volume (Fast), Peripheral Volume (Slow)
Time Frame Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 10 0
Median (95% Confidence Interval)
Unit of Measure: L
Central Volume
0.901
(0.79 to 1.07)
Peripheral Volume (Fast)
1.02
(1.0 to 1.03)
Peripheral Volume (Slow)
1.81
(1.8 to 1.83)
5.Secondary Outcome
Title Vancomycin Pharmacokinetics (Plasma Concentration vs Time Curve) in Children on Cardiopulmonary Bypass (CPB)
Hide Description Vancomycin pharmacokinetics measured as Elimination Clearance, Inter-tissue Clearance (Fast), Inter-tissue Clearance (Slow).
Time Frame Drug levels will be sampled only during the peri-operative time period (0 to 12 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Vancomycin pharmacokinetics were assessed only in the Cefazolin 25 mg/kg body weight and Vancomycin arm
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 10 0
Median (95% Confidence Interval)
Unit of Measure: L/min
Elimination Clearance
0.00695
(0.0067 to 0.0071)
Inter-tissue Clearance (Fast)
0.0554
(0.039 to 0.067)
Inter-tissue Clearance (Slow)
0.0202
(0.017 to 0.026)
6.Secondary Outcome
Title Count of Participants Experiencing Adverse Events Commonly Associated With Peri-operative Vancomycin Prophylaxis
Hide Description

Will evaluate for vancomycin associated pre or intraoperative adverse events:

  1. Hypotension requiring treatment
  2. Rash, flushing or Red Man's syndrome
  3. Other changes in vital signs (decrease in baseline 02 sat, increased heart or respiratory rate, elevated body temperature) felt to be associated with vancomycin administration
  4. An event associated with vancomycin administration which results in delay in surgery
Time Frame Adverse events to vancomycin will be assessed on each patient in the study during the time the patient is in the operating room (0-<24 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
Only the Cefazolin 25 mg/kg Body Weight and Vancomycin groups were assessed, the Cefazolin 30mg/kg body weight did not receive vancomycin
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin 30mg/kg Body Weight
Hide Arm/Group Description:

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin pre-operative prophylaxis: Cefazolin 30 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (30mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
Overall Number of Participants Analyzed 20 0
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
Time Frame Patients will be monitored for superficial SSIs for 30 days . Patients will be monitored for 30 days for deep SSIs if no foreign material was implanted and for 1 year if foreign material is implanted from the date of surgery.
Adverse Event Reporting Description Superficial SSI and adverse events related to vancomycin were assessed during the study period.
 
Arm/Group Title Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin30 mg/kg Body Weight
Hide Arm/Group Description

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.

Vancomycin hydrochloride: Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion). Repeat same dose intraoperatively at 8 hours or 12 hours if patient younger than 1 month of age.

Cefazolin 25 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery.
All-Cause Mortality
Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin30 mg/kg Body Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/12 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin30 mg/kg Body Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Cefazolin 25 mg/kg Body Weight and Vancomycin Cefazolin30 mg/kg Body Weight
Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chandra Ramamoothy
Organization: Stanford University
Phone: 650-723-5728
EMail: chandrar@stanford.edu
Layout table for additonal information
Responsible Party: Chandra Ramamoorthy, Stanford University
ClinicalTrials.gov Identifier: NCT01619982     History of Changes
Other Study ID Numbers: SU-11112011-8670
First Submitted: March 2, 2012
First Posted: June 15, 2012
Results First Submitted: June 21, 2017
Results First Posted: January 12, 2018
Last Update Posted: May 16, 2018